Marketing and Advertising of Pharmaceuticals- 2009

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Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals

Updated: June 2009

This report is a compendium of state laws, filed bills not enacted and related resources describing or affecting the marketing and advertising of pharmaceuticals, including disclosure of information relating to the practices.

several states have attempted to legislate different aspects of DTCA, including advertising, marketing, and doctor detailing and counter-detailing. This chart summarizes some of those bills. Generally, this chart does not include proposals that mention DTCA as a "source for a particular problem" or do not attempt to change DTCA practices. For example, proposals that refer to the addictive nature of an advertised drug or an over-the-counter product are not included in this listing, unless they aim to change the way prescription pharmaceuticals are advertised.In 25 states Legislative rules may allow for continuation or "carryover" to 2004 session.

Soaring drug costs have become a matter of concern for lawmakers and their constituents, especially those on fixed incomes. One question is just how much is advertising on television and in the popular press contributing to these increased costs.

At an estimated annual cost of $2.5 billion, pharmaceutical advertising to consumers has indeed made drug companies and their brand products household names.

A new analysis provided by the managed care industry reports that from 1999 to 2000, prescriptions written for the top 50 most heavily advertised drugs rose 24.6 percent, compared to 4.3 percent for all other drugs combined.¹ Drug manufacturing is a $122 billion industry, so a small increase in market share can reflect a multimillion-dollar boost for any particular company.

With pressure to try to curb the increased costs of prescription medicine, lawmakers are taking a closer look at the implications of pricey advertisements on state-funded programs.

Legislative lawyers point out that it is nearly impossible for individual states to control national advertisements, now regulated by the Food and Drug Administration. But this has not prevented some states from seeking solutions. Twelve considered bills regarding direct-to-consumer advertising in 2001, and at least one-West Virginia-enacted a law that gives the director of the West Virginia Public Employees Insurance Agency discretion to use "innovative strategies," such as requiring prescription drug manufacturers to show how much they're spending on advertising and what that adds to drug costs.

However the current director, Tom Susman, believes that West Virginia will most likely train a team of pharmacists to meet with and educate doctors about the fiscal impacts of prescribing higher priced and advertised drugs. "The pharmaceutical industry [representatives] don't talk about costs," Susman stated, "We go in and educate [doctors] about less expensive and therapeutic equivalent drugs and then they can make decisions to use less costly generics." Susman added that physicians [who participate in Medicaid] have an incentive to prescribe less costly drugs. "With only so much money to go around and using less expensive drugs, we have more money to put into paying the West Virginia physicians'."

Several states-such as Florida, Michigan, Oregon and Vermont-are creating drug lists for Medicaid patients that emphasize cheaper generic products over the popular advertised pharmaceuticals.
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1: Statistic from National Institute for Health Care Management Research and Education Foundation, Prescription Drugs and Mass Media Advertising, 2000. November, 2001. www.nichm.org

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Enacted State Laws:

2005-07 Marketing Laws and Bills
2001-02 Marketing Laws and Bills

Additional References and Sources

Recent Rx State Legislation (2008)
Other Rx State Legislation (2007)

NCSL defines direct to consumer advertising, marketing and disclosure legislation as any legislation that includes such things as:

-Rx manufacturers reporting gifts to doctors over a specific value.

-Reporting/restricting DTCA by Rx manufactures.

-Posting of Rx prices like AWP by Rx manufacturers or PBMs.

-Rx manufacturers disclosing side effects or warnings.

-Rx manufacturers reporting of detailers activities.

-Resolutions for federal agencies to act on DTCA issues.

any legislation that leads to sensitive data being disclosed and/or otherwise requested by the state that would otherwise not be disclosed by Rx manufacturers or PBMs in normal business practices.

This definition of disclosure does NOT include
-Restrictions on PBM practices and/or HMO disclosure of using PBMs.
-Reporting of adverse events by anyone other than Rx manufacturers.

As of June 2009, nine states: California (2004), Florida (2006) Maine (2003, 2005, 2007), Massachusetts (2008), Minnesota (1993), New Hampshire (2006), South Carolina (2006), Vermont (2002, 2007, 2009), West Virginia (2001) and the District of Columbia (2003, 2008), have laws or resolutions affecting pharmaceutical marketing. A separate Texas law (2007) requires a state-sponsored public awareness campaign to educate consumers about marketing solicitations by email or Internet. The specific provisions differ among these states - refer to details in the charts below. Note that states such as Maine and Vermont each have two or more separate laws, enacted in different years. Measures that passed both legislative chambers in California and Colorado but were vetoed are not included in the tally above. Read Two Drug Ads and Call Me in the Morning"-
(as published in the March 2002 edition of State Legislatures magazine)

For more recent DTCA and Disclosure Related State Bills and Laws - Please see http://www.ncsl.org/programs/health/drugbill07.htm and http://www.ncsl.org/programs/health/drugbill08.htm.

Examples of 2005-2007 DTCA and Disclosure Related State Bills and Laws- Updated through January 2007. For 2007 legislation click here. For 2008 legislation click here.

State/bill/ web link
gray = passed

Description / excerpts of bill text
(Bill status may change frequently - check state legislatures for most recent actions)

AK
HB 454,
HB 457
Rep. Guttenberg Would require disclosure of certain drug marketing costs.
(Filed 2/13/06; did not pass committee by end of regular session 5/9/06) |

AR
HB 2970
Rep. Norton
Would require disclosure of pharmaceutical marketing practices.
(Marketing portion of bill amended and deleted from the bill.)
(Filed 3/7/05; passed House 4/6/05; did not pass Senate 4/16/05) |

CA
AB 72
Assm. Frommer
Would create a Prescription drugs manufacturer requirement to submit a report to the State Department of Health Services of health studies or clinical trials that have been or are being conducted by or on behalf of that manufacturer pertaining to those drugs. Authorizes the Attorney General to bring civil actions to enforce the reporting requirements. (Filed 1/3/05; passed 2nd Reading Assembly, rescinded, sent to inactive file 6/2/05)

CA
AB 78
Assm. Pavley Would require a pharmacy benefits manager (PBM) to make disclosures to its purchasers and prospective purchasers, including specified information about the pharmacy benefit manager's revenues and its drug formularies, and to make specified disclosures to the public upon request. Would also establish certain standards and requirements for PBM contracts and the provision of drugs. Would impose requirements on the membership of a pharmacy and therapeutics committee for a PBM, and require a pharmacy benefits manager to meet conditions before substituting a prescribed medication. (Filed 1/18/05; passed Assembly 44y-34n; passed Senate 23y-14n 9/6/05, vetoed by governor 9/29/05)

CA
AB 95
Assm. Koretz

Would establish a program that would require manufacturers of drugs for life-threatening chronic conditions that are on the lists for Medi-Cal or the AIDS Drugs Assistance Program to pay the department a rebate equal to the costs of marketing that drug. Requires these manufacturers to disclose to the department all costs incurred in the marketing of the drugs to consumers and physicians. (Filed and sent to committee 5/4/05, 5/25/05)

CA
AB 1187
Assm. Wolk
Would require every pharmaceutical company to adopt a Comprehensive Compliance Program that includes policies related to interactions with health care professionals and limits on gifts or incentives provided to medical professionals.
(Filed and sent to committee 5/9/05)

CA
SB 163
Sen. Scott
Would require a pharmaceutical company entering into a contract with an agency of the state to disclose the percentage of its national operating budget that is expended on marketing purposes, and the percentage of its national operating budget expended on research and development. The bill would prohibit a state department or agency from entering into a contract with a pharmaceutical company in the absence of that disclosure.
(Filed and referred to committee 5/24/05; passed Senate 22y-15n, 5/31/05; carried over from 2005; did not pass Assembly committee 6/20/06) |

CA
SB 401
Sen. Ortiz Would further provide that marketing includes a written communication that is provided by a pharmacy to a patient about a different drug or treatment than that being dispensed by the pharmacy and that is paid for, or sponsored by, a manufacturer, labeler, or distributor of prescription drugs, as specified.
(Filed 4/12/05; passed Senate 23y-13n, 5/26/05; carried over from 2005 session; held in Assembly committee 8/17/06; did not pass committee by end of regular session 8/31/06)

CA
AB 2730
Assm. Nation Would prohibit the department from entering into a contract for a drug, and from placing a drug on the Medi-Cal contract drug list, if the drug has been promoted in California through the use of direct-to-consumer advertising.
(Filed and referred to committee 2/24/06; did not pass committee by end of regular session 8/31/06)

CA
AJR 49
Rep. Nation Would request that the United States Food and Drug Administration aggressively monitor and regulate direct-to-consumer advertising of prescription drugs by pharmaceutical companies, and would memorialize the President and the Congress to ban that advertising.
(Filed and referred to committee 4/3/06; adopted by Assembly 5/25/06; adopted by Senate 8/22/06)

CO
SB 06-1
Sen. Hagedorn Would require the Department of Health Care Policy and Financing to apply for federal authorization to enter into a multi-state drug purchasing pool for the benefit of Colorado's Medicaid recipients and eligible low-income residents; would establish the Colorado Cares Rx Program to allow for the purchase of discounted prescription drugs and authorize use of a preferred drug list; would require a pharmaceutical manufacturer to annually disclose to the Medical Services Board specific expenditure information, including expenditures for direct marketing to consumers and lobbying; would require the Board to disclose expenditure information to the public via the Internet; would refer the question of whether Colorado should enact these cost-saving measures to Colorado voters at the next general election.
(Filed 1/1/06; passed Senate 25y-10n, 4/26/06; passed House 64y-1n, 5/3/06; vetoed by governor 5/26/06) |

CT
HB 6183
Rep. Geragosian

Would require public disclosure of gifts by pharmaceutical companies to physicians licensed to practice in Connecticut.
(Filed and sent to committee 1/24/05; held in committee 5/05)

CT
HB 6623
Pub. Health Comm.

Would allow the University of CT to establish and operate and study a limited two-year pilot program, to allow appropriately qualified and trained academic detailers to visit licensed physicians in their offices to provide unbiased, evidence-based information on the diagnosis and treatment of selected illnesses, including information pertaining to the use of pharmaceuticals to assist the physicians in improving the quality of patient care and making cost-effective prescribing decisions for various diseases, while simultaneously focusing on patient outcomes.
(Filed and sent to committee 2/3/05; favorable committee report 4/20/05)

FL
SB 464
Sen. Campbell

Among other things: Would require the disclosure to the commission expenditures for advertising, marketing, and promotion, based on aggregate national data; not including clinical trial, free sample, or educational material costs.
(Filed; died in committee 5/6/05) |

FL

SB 1408
Health Care Comm.
Allows for the development and regulation of electronic prescribing practices and provides protection for consumers, including the prohibition of advertising. Establishes the information that must be contained in electronic prescriptions and provides mechanisms to ensure that patients receive brand name drugs, when such drugs are medically necessary, instead of generic substitutes when prescribed electronically. This bill would also establish disclosure and confidentiality requirements for medical and prescription records.
(SB 1408 filed 1/13/06; passed Senate 37y-0n, 3/29/06; passed House 118y-0n, 5/3/06; signed into law by governor as Chapter 2006-271, 6/22/06)

HI
HB 31
Rep. Takumi Would require marketing disclosure by drug manufacturers and require transparency in pharmacy benefit managers
(Filed and referred to committee 1/20/05; carried over, but did not pass by end of 2006 regular session) |

HI
HB 32
Rep. Takumi

Among other things: Would require drug manufacturers to disclose economic benefits of $25 or more provided to persons who prescribe, dispense, or purchase prescription drugs. Effective date July 1, 2099.
(Filed and referred to committee 1/20/05; carried over, but did not pass by end of 2006 regular session) |

HI
SB 1440
Sen. Campbell, Lerman , Menor

Would require marketing disclosures by drug manufacturers, and would require transparency in pharmacy benefit managers.
(Filed and referred to committee 1/27/05; carried over, but did not pass by end of 2006 regular session) |

HI
HB 1869
Rep. Would require that a prescription drug manufacturer post on the publicly accessible Internet web site of the federal National Institutes of Health or another publicly accessible web site, the name of the entity that conducted the clinical trial, a summary of the, the dates of the trial, and the results of the clinical trial, including potential or actual adverse effects of the drug. Would also require that a manufacturer may not present a regulated advertisement, unless that advertisement meets federal and state requirements concerning misbranded drugs and devices and prescription drug advertising. Effective date would begin October 15, 2007.
(Filed and referred to committee 1/19/06; passed House, 3/3/06; favorable Senate committee report 3/24/06; measure deferred 4/4/06; did not pass by end of 2006 regular session)

HI
HB 1875
Rep. Schatz Would lower prescription drug costs for individuals, businesses, and the state and protect the health of Hawaii residents by deterring the practice of unethical gift giving by drug manufacturers. This bill would require drug manufacturers to disclose the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit in excess of $25 that is provided in connection with detailing, promotional or other marketing activities by the manufacturer to any physician, hospital, nursing home, pharmacist, health benefit plan administrator or any other person in the state authorized to prescribe, dispense or purchase prescription drugs.
(Filed and referred to committee 1/19/06; committee recommends measure be deferred 1/30/06; did not pass by end of 2006 regular session) |

IL
HB 656
Rep. Franks

Would create the Prescription Drug Ethical Marketing Act. Would require every manufacturer and labeler that sells prescription drugs in the State to disclose to the Director the value, nature, and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing or promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any person in the State authorized to prescribe or dispense prescription drugs. Would require the Director to report to the Governor and the General Assembly on the disclosures. Would provide exceptions to the disclosures and for injunctive relief and civil penalties for failure to disclose. (Filed 1/28/05; carried over from 2005 regular session; held in committee 12/06)

IL
HB 2768
Rep. Stephens

Would require a wholesale drug distributor or pharmacy benefit manager that has entered into a contract with the State to sell or negotiate the sale of a prescription drug to the State at a particular price, then, upon the request of any pharmacy domiciled in this State, the wholesale drug distributor or pharmacy benefit manager must disclose that price and make that prescription drug available to the pharmacy at that same price during the period that the contract with the State is in effect, regardless of the quantity of the drug purchased by the pharmacy. Would only apply to contracts entered into after the effective date of this act.
(Filed 2/22/05; pending in committee 7/05)

IA
HF 503
Rep. Hogg
Would prohibit a pharmaceutical marketer from offering or providing to any practitioner, hospital, health care facility, pharmacist, or health benefit plan administrator, or any other person in the state authorized or licensed to dispense, distribute, or purchase prescription drugs, any gift not otherwise exempt under the bill. Would specify the gifts exempt from the prohibition; direct pharmaceutical manufacturing companies on an annual basis to disclose gifts made to the board of pharmacy examiners; direct pharmaceutical manufacturing companies on an annual basis to provide the name and address of the individual responsible for the company's compliance with the bill; provide that all trade secrets are to be kept confidential; and authorize the attorney general to bring an action for injunctive relief, costs, and attorney fees and to impose a civil penalty for failure of a company to disclose required information.
(Filed 3/1/05; did not pass committee by end of regular session 5/23/05*) |

ME
LD 225
Sen. Mayo Would require registration and continuing education of pharmaceutical sales representatives or "detailers."
(Filed; died 4/12/05) |

ME
HP 1141/ LD 1618
Rep. Lerman

Prohibits pharmaceutical companies from advertising on television, radio or in print unless material meets federal guidelines. Also includes clinical trial requirements that manufacturers "shall post on the public website of the federal National Institutes of Health or another publicly accessible website information concerning any clinical trial that the manufacturer conducted or sponsored beginning October 15, 2002; includes a fee for Rx manufacturers that advertise in the state for maintaining the clinical trial database.
(Filed 5/3/05; passed House 73y-72n, 6/10/05; passed Senate 6/10/05; signed into law by governor as Chapter 392, 6/15/05)

ME
LR 1702/ LD 1541
Sen. Weston

Limits the pricing information that a pharmaceutical manufacturer must report to the state to average manufacturer price (AMP) and best price as defined by federal law. It eliminates the instructions on calculating other pharmaceutical pricing information and the requirement to describe the methodology for calculating pricing information that is reported. It also strengthens the confidentiality protection afforded to the reported information.
(Filed 4/4/05; passed to be enacted by House and Senate 6/9/05; signed into law by governor as Chapter 402, 6/17/05)

ME
LR 1703/LD 1539
Sen. Brennan

Would delay implementation of the deadline for filing reports regarding marketing activities by pharmaceutical manufacturers. Would also clarify that the Department of Health and Human Services may disclose that information to an entity that provides services to the department under the laws requiring those reports, but specifies that such disclosure does not change the confidential status of the information.
(Filed; passed House 5/24/05; passed Senate and sent to governor 5/25/05)

ME
HP 5 / LD 4
Rep. Faircloth
Prohibits the sale of pharmaceutical information that identifies directly or indirectly the practitioner who ordered the prescription drug; establishing a mechanism for confidentiality protection through an opt-out procedure, comparable to the federal "Do Not Call List," utilizing the licensing and relicensing process for prescribers. The procedures include methods for filing with the Maine Health Data Organization to protect confidentiality of prescriber-identifying information by restricting its use to non-marketing purposes.
(Filed 1/3/07; passed House; passed Senate 6/20/07; signed into law by governor as Public Law Act 460, 6/29/07)
NEWS UPDATE ME: Medical data law disputed in lawsuits by The Associated Press, Portland Press Herald, 8/31/07. Companies that collect, analyze and sell medical data filed lawsuits Wednesday in federal courts in Maine and Vermont, challenging laws in the two states that make doctors' prescription-writing habits confidential.

MA
HB 2659
Rep. Spellane

Would require disclosure of certain gifts made by pharmaceutical companies to persons authorized to prescribe or dispense prescription drugs.
(Filed; favorable report with S 1270, 3/28/06; did not pass committee by end of session, 1/2/07) |

MA
HB 3706
Rep. Reinstein Would prohibit all pharmaceutical companies from advertising on any media in the Commonwealth or by any other means.
(Filed 1/25/05; date extended to 1/2/07; did not pass committee by end of session, 1/2/07) |

MA
SB 402
Sen. Montigny
Would designate an assistant attorney general to coordinate the activities of the office relating to prescription drug pricing and marketing practices within the state. Such activities shall include, but not be limited to, the investigation and prosecution of Medicaid fraud and other fraudulent drug pricing schemes disadvantaging the commonwealth or its citizens, including the filing of false or misleading reimbursement claims or price reports, the investigation and prosecution of unfair and deceptive acts or practices by pharmaceutical manufacturing companies or their agents, including misconduct in the marketing of prescription drugs to prescribers and the exploration of the relationship between the pharmaceutical industry and the public charities of the commonwealth. Would require doctors and hospitals to report gifts or anything of value given to them by a pharmaceutical company or representative. (Filed 1/26/05; did not pass committee by end of session, 1/2/07) |

MA
SB 2011
Sen. Spilka
Would urge the United States Congress and the Department of Health and Human Services to recognize the problems caused by direct-to-consumer advertising of prescription drugs by pharmaceutical companies.  Would also urge the study of effects of direct-to-consumer advertising of prescription drugs by pharmaceutical companies on the health care system, on the prescriber/patient relationship, on the quality of care received by patients, and on the increasing costs of prescription medications. Would urge to aggressively monitor and regulate direct-to-consumer advertising of prescription drugs by pharmaceutical companies, pending Congressional action to limit, ban, or place increased restrictions on such advertising. Would urge to limit or ban direct-to-consumer advertising of prescription drugs by pharmaceutical companies, or alternatively, to require that advertisements: (1) remind consumers that prescribers and pharmacists are the best sources of information about appropriate medical treatment and drug therapy; (2) explicitly state the success and failure rates of drugs and compare them with other common products and "no treatment"; (3) mention alternate treatments by name and class; and (4) refer consumers to independent sources of drug information.
(Filed 1/26/05; favorable committee report 3/29/06; did not pass by end of session 1/2/07)

MA
H 2683,
S 399
Sen. Montigny,
Rep. Jehlen

Would establish a prescription drug “fair pricing program”, including: 1) a discount drug program for Medicare-eligible residents with incomes over 188 percent of FPL, and other residents with income up to 300 percent of FPL (discounts would be based on manufacturer rebates comparable to Medicaid rebates); 2) creation of a “statewide, uniform preferred list of covered prescription drugs” and a multi-agency bulk purchasing program; 3) consumer safeguards and an appeal process for access to products requiring prior authorization or listed as non-preferred; 4) prohibition of any pharmaceutical manufacturer from giving gifts of any value at any time to physicians or providers; 5) requiring membership in the National Legislative Association on Prescription Drug Prices (NLARx).
(Filed 1/26/05; attached to a study order H4994, 5/30/06; did not pass committee by end of session, 1/2/07) |

MN
HF 1178 / SF 982
Rep. Thissen
Would require financial and information disclosure of prescription drug purchasing information and arrangements.
(Filed and referred to committee 2/21/05; carried over, but did not pass by end of 2006 regular session) |

MN
SF 1999 / HF 1898
Sen. Solon Would require a certificate of authority for pharmacy benefits managers; allowing access to certain information; requiring disclosures to certain entities; setting standards and responsibilities of pharmacy benefits managers.
(Filed and referred to committee 3/17/05; carried over, but did not pass by end of 2006 regular session) |

MS
SB 2669
Sen. Williamson Would require Rx manufacturers to disclose gifts, fees, payments or other economic benefit over $25 provided to health care providers for promotional and marketing activities.
(Filed 1/17/05 and died in committee 2/1/05) |

MT
HB 532
Rep. Gallik

Would require a pharmaceutical manufacturer that advertises the drug for sale in the state and receives revenue from those sales to disclose all of the business costs of advertising the drug as a percentage of the total revenue derived from the sale of the drug in the state. Would also provide for enforcement and penalties. (Filed 2/2/05 and sent to committee; missed deadline for revenue bill transmittal 4/4/05; no further action before end of session) |

MT
HB 563
Rep. Dowell

Would require Rx manufactures to disclose gifts over $25, not including grants for education, clinical trials, or other bona fide related research work. (Filed 2/5/05; third reading failed 3/9/05; and missed deadline for revenue bill transmittal 4/4/05; no further action before end of session) |

NV
AB 66
Rep. Conklin

Would require reporting of certain gifts or other economic benefits provided by wholesalers or manufactures regulated by State Board of Pharmacy. (Filed, passed Assembly 26y-16n, did not pass Senate by deadline 5/28/05) |

NH
SB 211
(LR 972)
Sen. Letourneau

Would require pharmaceutical manufacturing companies to disclose to the secretary of state the value, nature, and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing, promotional, or other marketing activities by the company, directly or through its pharmaceutical marketers, to any prescriber in the state, or those who dispense or purchase prescription drugs. Disclosure would be made on a form and in a manner prescribed by the secretary of state. (Filed 1/6/05; passed Senate 3/10/05; held in House committee 4/12/05, 6/05; referred for interim study 1/18/06; did not pass by end of 2006 regular session) |

NH
HB 1346
Rep. Rosenwald
Prohibits individual prescription information from being transferred or sold for any commercial purpose except for the limited purpose of reimbursing the pharmacy. Commercial purposes include advertising, marketing, promotion, or any activity that could be used to influence sales or market share of a pharmaceutical product, influence or evaluate the prescribing behavior of an individual health care professional, or evaluate the effectiveness of a professional pharmaceutical detailing sales force. It does not prevent the collection of such data, nor does it prevent its use for reimbursement, research, utilization review, compliance, education, or as provided by law. Commercial use of prescriber identity is also allowed by zip code or medical specialty. Effective date: June 30, 2006.
(Filed 1/4/06; passed House 2/22/06; passed Senate 22y-0n, 5/4/06; final passage, enacted 5/24/06; 6/7/06; signed into law by governor as Chapter 328, 6/30/06)

NH
HB 1542
Rep. DeJoie Would enhance consumer protection in the advertisement of prescription drugs and services and enhance the efforts of the Food and Drug Administration in the regulation of drug advertising.
(Filed and referred to committee 1/4/06; did not pass by end of 2006 regular session) |

NH
HB 703
Rep. DeJoie

Would clarify advertisements for prescription drugs. Would also require pharmaceutical manufacturers to disclose certain information on gifts to doctors to the secretary of state. (Filed and referred to committee 1/26/05; carried over, but did not pass by end of 2006 regular session) |

NJ
AB 1801
(same as A 2839 from 2003)
Rep. Roberts
Would requires pharmaceutical manufacturers to disclose gifts, fees and other economic benefits provided to health care providers for promotional and marketing purposes to DHSS. (Filed and sent to committee 1/13/04)

NM
SB 824
Sen. McSorely

Would require pharmaceutical manufacturers to report any gift or item of value given to a doctor over $25.
(Filed 2/9/05, did not pass by end of session 3/19/05) |

NY
AB 1027
Assm. Brodsky

Would prohibit pharmaceutical manufacturers and distributors from deducting the costs of advertising drugs to consumers from their personal or corporate income taxes. (Filed 1/18/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

NY
AB 2769
Assm. Wolk, Assm. Brodsky (same as
SB 3695
Sen. Spano)

Would require manufacturers and labelers of prescription drugs dispensed in this state which engage in marketing activities in the state to annually report marketing expenses to the department of health; imposes a $10,000 civil fine for failure to report.
(Filed 3/29/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

NY
AB 3056
Assm. Brodsky
(same as
SB 4538)

Would subject manufacturers of prescription drugs or medical devices who engage in direct-to consumer-advertising to civil liability where adequate warnings are not provided; applies to drugs or devices requiring a health care provider's prescription for dispensing; provides that a jury shall consider, as a question of fact, whether or not the warnings were adequate.
(Filed 1/31/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

NY
AB 4408
Assm. Heastie
(same as
SB 1909
Sen. Robach)

Would require manufacturers engaging in direct-to-consumer advertising of prescription drugs to clearly state the primary function of the prescription drug in such advertisement; defines prescription drug. (Filed 2/10/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

NY
AB 4415
Assm. Lavelle

Would require marketing costs for prescription drugs to be reported to   the department of health for the purpose of assisting the state in its role as a purchaser of prescription drugs and an administrator of prescription drug programs; authorizes state and municipal agencies to unite as a single-source buying block in order to establish a stronger marketing position regarding the negotiation of prescription drug prices with pharmaceutical companies; allows certain private entities to participate in the buying block as well.  (Filed 2/10/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

NY
AB 4763
Assm. Burling Would require pharmaceutical drug manufacturers and wholesalers to annually report to the New York State Department of Health, for disclosure to the general public, all of its gifts to health care practitioners that prescribe drugs when such gifts have a value of $75 or more.
(Filed 2/14/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

NY
SB 696
Sen. Maziarz
(same as
A 5574
Sen. Grannis)

Would require pharmaceutical manufacturers and wholesalers to annually report to the NY Dept. of Health, for disclosure to the general public, all of its gifts to health care practitioners that prescribe drugs when such gifts have a certain value. (Filed 1/19/05; A 5574 amended & passed Assembly 6/23/06/05; held in Senate committee 7/06) |

NY
SB 2258
Sen. Krueger

Would require the Commissioner of Pharmaceuticals to conduct a cost benefit analysis of pharmaceutical advertising and promotional activities associated with the provision of prescription drugs to citizens in the state. (Filed 2/10/05; carried over from 2005 session; held in committee at end of formal sessions, 7/06) |

OH
HB 112
Rep. Skindell Would require manufacturers and labelers of drugs to disclose to the state the value, nature, and purpose of certain gifts, fees, payments, subsidies, and other economic benefits they provide in connection with pharmaceutical detailing, marketing, or promotion.
(Filed and referred to committee 3/19/05; carried over from 2005 regular session; no further action before end of formal sessions, 12/06)|

OK
HB 1542
Rep. Peterson

Would require the exploration of reporting of certain advertising, promotion and marketing costs by pharmaceutical manufacturers. (Filed 2/7/05; Rx affordability sections deleted & did not pass by end of regular session 5/27/05*) |

OK
SB 896
Sen. Nichols

Would require the exploration of reporting of certain advertising, promotion and marketing costs by pharmaceutical manufacturers. (Filed 2/7/05 and sent to committee; 2/28/05 original title and text stricken and replaced with different topic) |

OK
HB 1673
Rep. Nations

Would create the Oklahoma Pharmaceutical Availability and Affordability Council, empowered to consider strategies to manage the increasing costs of prescription drugs and increase access to prescription drugs for all citizens; assess enactment of fair prescription drug pricing policies; explore discount prices or rebate programs for seniors and persons without prescription drug coverage; consider coordinated PDLs, generic drugs and other approaches; requires disclosure of marketing practices; requires cooperation of all state agencies.
(Filed and referred to committee 2/7/05; carried over, but did not pass by end of 2006 regular session) |

OK
HB 2914
Rep. D. Morgan A manufacturer may not advertise a prescription drug for a clinical trial in a television broadcast, radio broadcast or printed material, unless the manufacturer has disclosed to the State Department of Health the name of the entity that conducted or is conducting the clinical trial, a summary of the purpose of the clinical trial, the dates during which the trial has taken place, information concerning the results of the clinical trial, including potential or actual adverse effects of the drug, and any other information determined by the Department to be relevant.
(Filed and referred to committee 2/6/06; did not pass by end of 2006 regular session) |

OR
HB 2817
Rep. Tomei

Would require pharmaceutical manufacturing companies to disclose certain economic benefits provided in conjunction with marketing of prescription drugs, including imposition of civil penalty for failure to disclose.
(Filed; in committee upon adjournment (did not pass) 8/5/05) |

PA
HB 613
Rep. Allen

Would regulate pharmacies, manufacturers and wholesalers that advertise for sale or sell drugs or devices via the Internet. Provides for powers and duties of the Office of Attorney General. Imposes penalties. (Filed 2/15/05; in committee 9/05)

PA
HR 114
Rep. Walko

Concurrent Resolution would direct the Health Care Cost Containment Council to conduct a study on the impact of prescription drug advertising and promotion on drug prices in Pennsylvania. (Filed and referred to committee 3/1/05; carried over from 2005 regular session; did not pass by end of 2006 regular session) |

PA
SB 320,
SB 321

Would provide for annual expense reports and for disclosure by pharmaceutical marketers. Imposes penalties. (Filed 2/18/05; carried over from 2005 regular session; did not pass by end of 2006 regular session) |

RI
HB 6141
Rep. Rice

Would require disclosure from manufacturers of prescription drugs regarding gifts given to persons authorized to prescribe and dispense prescription drugs. This act would take effect on July 1, 2005. Initial disclosure would be made on or before February 1, 2006 for the six (6) month period July 1, 2005 to December 31, 2005. (Filed 3/2/05; in committee 6/05; no further action before end of session) |

RI
SB 2944
Sen. Walaska Would regulate pharmaceutical companies advertising in the state, and would include disclosure of clinical trials of prescription drugs.
(Filed and referred to committee 3/15/06; did not pass by end of 2006 regular session) |

SC
HB 3711
Rep. Cobb-Hunter Would enact the Prescription Drug Discount Card Registration Act; providing for registration with the Department of Consumer Affairs of persons and representatives engaged in the sale, marketing, promotion, advertisement, or distribution of prescription drug discount cards or other purchasing devices. (Filed and referred to committee 3/8/05; re-referred to committee 3/16/06; passed House 4/26/06; passed Senate 6/1/06; House concurred 6/1/06; became law without governor's signature as Act 377, 6/14/06)

SD
SB 57
Committee on Judiciary Would make it a deceptive or unfair trade practice to sell, market, promote, advertise or otherwise distribute any card or other purchasing mechanism or device that is not insurance that purports to offer discounts or access to discounts from pharmacies for prescription drug purchases if: (a) the card or other purchasing mechanism or device does not expressly state in bold and prominent type, prevalently placed, that discounts are not insurance; (b) the discounts are not specifically authorized by a separate contract with each pharmacy listed in conjunction with the card or other purchasing mechanism or device; or (c) the discount or access to discounts offered, or the range of discounts or access to the range of discounts, is misleading, deceptive or fraudulent, regardless of the literal wording.
(Filed and referred to committee 1/10/06; passed Senate 31y-3n, 1/24/06; did not pass House as amended 2/23/06) |

TN
HB 1093
Rep. McMillan
SB 1111
Sen. Crutchfield

Would require the commissioner of commerce and insurance to conduct a study of the effects of prescription drug advertising in Tennessee and to report to the general assembly by January 15, 2006. Filed and referred to committees 2/3/05; carried over, but did not pass by end of 2006 regular session) |

TX
HB 1676
Rep. Delisi,
Sen. Van de Putte
Requires the TX Attorney General to develop a public awareness campaign to educate consumers about solicitations by email or Internet, including information on distinguishing reputable pharmacies from unlicensed or fraudulent sales. The campaign may use brochures, advertisements and similar outreach and may accept grants and donations to fund the effort.
(Filed 2/20/07; HB 1676 passed House 145y-0n, 3/28/07; passed Senate 4/26/07; signed into law by governor 5/14/07)

VT
HB 225
Rep. Fisher
SB 93
Sen. Sears

Would prohibit the advertising of prescription drugs in broadcast media.
(Filed and referred to committee 2/10/05; carried over, but did not pass by end of 2006 regular session) |

VT
S 115
S. Finance Comm.
Increases "transparency of prescription drug pricing and information" by limiting "fraudulent" advertising of prescription drugs to consumers and health care professionals, requiring notice to clients by pharmacy benefit managers that certain types of contracts are available, establishing an evidence-based education program, providing additional pricing information including "AMP" and "Best Price," to the Medicaid program from drug manufacturers and requiring disclosure of education programs funded by drug manufacturers. Also establishes regulation of PBMs including requiring that all financial and utilization information requested by a health insurer be provided, disclose the costs and financial arrangements with any formulary management, drug substitution including rebate and discount agreements. Such disclosures may be defined as confidential and not subject to court inquiry.
(Filed 2/23/07; amended 3/20/07; passed Senate 28y-1n, 4/4/07; passed House 89y-44n, 5/4/07; signed into law by governor as Chapter 80, 6/9/07)
NEWS UPDATE: VT: Companies sue state over prescription drug law By Rutland Herald, 8/80/07. Three data-collection companies sued the state of Vermont Wednesday over a provision in the new prescription drug law that would conceal from public view what drugs doctors are prescribing to their patients.

WA
HB 1889
Rep. Morrell
SB 5149
Sen. Kohl-Welles

Would require the disclosure of gifts made by pharmaceutical manufacturers to persons who prescribe prescription drugs.
(Filed 2/9/05; reintroduced 1/9/06; did not pass by end of 2006 regular session 3/8/06) |

WA
SB 5986
Sen. Kline Would revise prescription drug product liability, by stating that manufacturers who advertise directly to consumers remain liable despite warning prescribers of “proper use and attendant dangers.”
(Filed  2/18/05; reintroduced 1/9/06; did not pass by end of 2006 regular session 3/8/06) |

WI
AB 357 same as SB 212
Rep. Sherman Would prohibit advertising for prescription drugs to the general public. This would not apply to an advertisement that is broadcast from or is mailed or shipped to the ultimate recipient of the advertisement from outside this state or to advertising sent directly to pharmacists or to practitioners who are authorized to prescribe prescription drugs.
(Filed 4/22/05 & 5/24/05; carried over, but did not pass by end of 2006 regular session) |

WY
SF 124
Sen. Scott

Would prohibit payment in exchange for prescribing or recommending prescription and nonprescription medication, medical devices and medical equipment; prohibit receipt of gifts from sellers of prescription and nonprescription medication, medical devices and medical equipment; providing for penalties; providing exceptions; providing for inclusion of price information with free samples; and providing for an effective date. (Filed 1/14/05 did not pass committee 1/21/05) |

Examples of 2003-2004 DTCA and Related State Bills and Laws- Updated as needed

State/bill/ web link
gray = passed

Description / excerpts of bill text
(Bill status may change frequently - check state legislatures for most recent actions)

AK
H 328
Rep. Gara

Would allow a pharmacy to advertise that the pharmacy offers a senior prescription drug discount plan under certain conditions. "A pharmacy may participate in the Alaska senior prescription drug discount plan, In order to advertise that the pharmacy is part of the plan, a pharmacy, upon presentation of a valid prescription for a prescribed drug covered under the program and the patient's Medicare card, may not charge a Medicare patient a price for the prescribed drug that exceeds the drug reimbursement rate set by the state for the Medicaid program.
(Filed 5/20/03; no additional action before end of session)|

CA
AB 103
Reyes

Would require a pharmaceutical manufacturing company to annually disclose to the board economic benefits the company provides in connection with its marketing activities. The bill would also require the board to report annually to the governor and the legislature regarding these disclosures.
(Filed 1/10/03; sent to committee 3/26/03; failed to pass Assembly 6/5/03), died on inactive file 2/4/04)|

CA
AB 1437
Koretz

Would define pharmaceutical marketing practices more specifically between pharmaceutical manufacturing companies and physicians.
(Filed 2/21/03, sent to committee 3/20/03; did not pass committee 4/29/03*; language deleted 1/5/04)|

CA
SB 1765
Sen. Catania

Requires pharmaceutical companies to adopt a Comprehensive Compliance Program that is in accordance with a related federal government publication, to include policies on marketing interactions with health care professionals and limits on gifts and incentives to medical or health professionals, including "specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company may give or otherwise provide to an individual medical or health care professional."
(Initial language, deleted from final bill) Would prohibit a pharmaceutical or drug manufacturer from giving gifts to medical or health professionals, with exceptions for drug samples, educational materials, low-cost items primarily associated with a health care professional's practice, and up to 4 meals per year.
(Filed 2/20/04; passed Senate 21y-14n, 4/22/04; amended & passed Assembly 8/23/04; signed into law by governor as Chapter 927, 9/29/04) |

CA
SJR 24
Sen. Ortiz

LAW

Would memorialize the President and Congress of the United States to recognize the problems caused by direct-to-consumer advertising of prescription drugs by pharmaceutical companies and to take specified actions in the regulation of consumer advertising of prescription drugs.
(Filed 2/25/04; passed Senate 3/30/04; passed Assembly 8/10/04; Chaptered by Secretary of State Res. Chapter 139, Statutes of 2004.)

CT
H 6273
Rep. Fleischmann

Would require drug companies and drug company representatives to disclose incentives provided to health care providers.
(Filed and sent to committee 1/28/03; merged into HB 6473 2/20/03; did not pass by end of session)|

CT
H 6473
Joint Committee on General Law

Would require pharmaceutical manufacturing companies to disclose incentives provided to health care providers.
(Sent to committee 2/20/03; failed joint favorable deadline 3/25/03)|

CT
S 767
Sen. Handley

Would prohibit any drug company from giving gifts to doctors they are seeking to do business with.
(Sent to committee 1/27/03; no action before end of session)|

CT
S 981
Health Committee

Would establish a board to gather and disseminate information on prescription drug prices, including pharmaceutical company marketing information and assistance programs.
(Sent to committee 2/25/03; no action before end of session)|

CT
S 1118
Health Committee

Would require doctors to disclose gifts, fees, payments, subsidies or other economic benefits received from pharmaceutical companies.|
(Filed & sent to committees 3/12/03 & 4/30/03; no additional action before end of session) |

CT
S 1119
Health Committee

Would require pharmaceutical companies to disclose to the Department of Public Health all advertising and marketing costs associated with each prescription drug sold in the state.
(Sent to committee 3/12/03; died in committee 5/13/03) |

DC
B15-569
Councilmember Catania

Enacts the Rx Access Act of 2003, requiring the Dept. of Health to run an AccessRx subsidy program for low-income elderly District residents (eligibility: age 62 or older with household income not more than 200 percent of federal poverty), with enrollees to pay 20 percent of the cost of prescriptions. Also establishes discount prices for qualified uninsured residents (eligibility: any District resident with household income not more than 350 percent of federal poverty, not enrolled in any insurance program) . Requires drug manufacturers to enter into rebate agreements for products sold to publicly funded programs, with public disclosure and possible prior authorization restrictions for products lacking rebate agreements. Includes requirements for disclosure and reporting of Rx marketing costs by manufacturers; also permits negotiations with other states or jurisdictions for bulk purchasing. Also provides that the Department "shall investigate purchases from outside the U.S. Also regulates PBMs, including establishing a legal "fiduciary duty" to any covered entity or customer, transparent business practices, pass through of payments and disclosure of rebates from manufacturers.
(Filed 11/4/03; Passed City Council 3/24/04; signed by mayor as Act 15-410) |
[Also requires ratification by the U.S. Congress]

HI
HB 13
Rep. Thielen

Would establish a prescription drug cost control education program to provide physicians with unbiased information on cost-effective use of prescription drugs; requires prescription drug manufacturers to disclose certain expenditures.
(Filed 1/15/03; sent to committee 2/14/03; no action before end of session*)|

HI
HB 19
Rep. Takumi

Would require pharmaceutical manufacturing companies to disclose to the board of pharmacy the value, nature, and purpose of any gift, payment, or other economic benefit worth $25 or more provided with promotional or other marketing activities to physicians, hospitals, nursing homes, and pharmacists.
(Filed 1/15/03; sent to committee 2/4/03; no action before end of session*)|

HI
HB 1920
Rep. Takumi

Would establishes ethical marketing requirement for prescription drugs and require manufacturers and labelers who sell prescription drugs in Hawaii to disclose the value, nature, and purpose of gifts and other economic benefits given doctors and other health care providers in connection with detailing, marketing, or promotions.
(Filed 1/23/04; sent to committee 1/26/04)

HI
SB 776
Sen. Kanno

Would require pharmaceutical manufacturing companies to disclose to the board of pharmacy the value, nature, and purpose of any gift, payment, or other economic benefit worth $25 or more provided with promotional or other marketing activities to physicians, hospitals, nursing homes, and pharmacists.
(Filed 1/17/03; sent to committee 1/22/03; no action before end of session*)|

ID
HB 289
Rep. Jaquet

Would make available data on drug industry marketing and promotional spending in Idaho. Specifically it should provide information of gifts and promotions for doctors and health care providers. Would require that pharmaceutical manufacturers disclose the value, nature and purpose of any gift, fee, subsidy, or other economic benefit provided in connection with detailing, promotional, or other marketing activities by the company through its pharmaceutical marketers to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or anyone who is authorized to prescribe, dispense, or purchase prescription drugs in Idaho.
(Filed 2/20/03; sent to committee 2/21/03; no action before end of '03 session)|

IL
HB 343
Rep. Jakobsson

Would add pharmaceutical companies to the list of entities prohibited from sharing medical information about a patient.
(Filed 1/27/03; passed House 3/28/03; sent to Senate committee 5/14/03; no action before end of '03 session*

IL
HB 4233
Rep. Franks

Would require every manufacturer and labeler that sells prescription drugs in the State to disclose to the Director the value, nature, and purpose of any gift, fee, payment, subsidy, or other economic benefit provided in connection with detailing or promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person in Illinois authorized to prescribe or dispense prescription drugs.
(Filed 1/30/04; consideration postponed, 3/23/04)

IL
SB 60
Sen. del Valle

Would require pharmaceutical manufacturers to disclose advertising expenditures and promotional costs. The Department of Public Health shall require any pharmaceutical company that provides prescription drugs in Illinois to disclose to the Department, in a manner and fashion designated by the Department by rule, all prescription drug advertising and promotion costs. The Department must then conduct a cost/benefit analysis to determine (Faircloth WouldMayo WouldChery WouldWelch Wouldi) the impact of these costs on prescription drug prices and (ii) the impact on Illinois residents of any increase of the prices and costs of prescription drugs that is attributable to the advertising and promotional activities.
(Filed 1/22/03; sent to committee 3/14/03; no action before end of '03 session*)

IN
HB 1909
Rep. Welch

Would require pharmaceutical manufacturers to report information concerning gifts and payments that are made to a person who prescribes or purchases prescription drugs. Excludes certain gifts and payments from disclosure.
(Filed 1/23/03 and sent to committee; no action before end of session)|

KY
HCR 66
Rep. Chery

Would urge the United States Congress, Department of Health and Human Services, and Food and Drug Administration to limit, ban or otherwise impose strict standards on direct-to-consumer advertising of drugs by pharmaceutical companies.
(Filed 1/10/03; sent to committee; no action before end of session 3/25/03)|

KY
HCR 59

Non-binding resolution would urge the U.S. Congress and the Dept for Health and Human Services to limit or ban direct to the consumer advertising of prescription drugs.
(Filed 1/8/04 and sent to committee)

ME
LD 132/ S 55
Mayo

Would require that a manufacturer or labeler of prescription drugs dispensed that employs, directs or utilizes marketing representatives in this state shall report the costs of advertising and promotional expenses for prescription drugs in this state as provided in this section. (Filed 1/21/03 and sent to committee, died in committee 4/15/03)|

ME
LD 254/H 209

Would require full disclosure of prescription drug marketing costs.
(Filed 1/23/03 and sent to committee; passed to be enacted by both House and Senate 5/28/03; signed by governor 6/5/03)

ME
LD 1256
Rep. Faircloth

Would prohibit unethical drug marketing practices that are in violation of the drug industry's own code of ethics including practices that induce doctors to violate the American Medical Association's code of ethics.
(Filed 3/6/03; sent to committee 3/13/03, died in committee 5/9/03)|

MD
HB 188
Del. Moore

Would require specified pharmaceutical manufacturing companies to submit to the Maryland Health Care Commission on a specified form specified information relating to the detailing, promotional, and marketing activities of specified pharmaceutical manufacturing companies; would exempt specified pharmaceutical manufacturing companies from the reporting requirements of the Act; would require the Commission to compile a specified report and keep information about trade secrets confidential.
(Filed 1/29/03 and sent to committee; no action by end of session 4/7/03)|

MD
HB 548
Same as S 537
Del. Boutin

Would authorize specified health occupation boards to reprimand, place on probation, suspend, or revoke the license of specified health care providers for accepting any gifts greater than $50 from a pharmaceutical manufacturing company or a pharmaceutical marketer; would prohibit specified health care providers from accepting any gifts, other than samples of pharmaceutical products and information, greater than $50 from a pharmaceutical manufacturing company or a pharmaceutical marketer.
(Filed 2/6/03 and sent to committee; no action by end of session 4/7/03)|

MD
HB 519
Del. Boutin

Would require a pharmaceutical manufacturing company to disclose marketing information; requires the state Pharmacy Board to report annually on the disclosures; requires marketers to register with the Board, pay a fee, and certify adherence to a specified code of ethics before practicing pharmaceutical marketing in the state.
(Filed 1/29/04; did not pass by end of regular session, 4/12/04) |

MA
H 3115
Rep. Reinstein

Would prohibit the advertising of pharmaceuticals in all media forms within the Commonwealth of Massachusetts.
(Filed 1/1/03, reported favorably by committee and referred to committee 7/31/03; no action before end of '03 session*)

MA
H 3762
Rep. Jehlen

Along with other items, would require registration and reporting of pharmaceutical company marketing activities to doctors.
(Filed 1/01/03; House referred to committee and Senate concurred; no action before end of '03 session*)

MA
S 551
Sen. Montigny

A petition to discourage fraudulent marketing practices by the pharmaceutical industry.
(Filed 1/1/03 and sent to committee; no action before end of '03 session*)

MA
S 560
Sen. Montigny

Would ban gifts from pharmaceutical manufacturers to doctors.
(Filed 1/1/03 and sent to committee with S618 6/26/03; no action before end of '03 session*)

MA
S 618
Sen. Moore

Would require all Hammerstron Wouldprescribers receiving gifts or honoraria from people who manufacture, sell, market or distribute prescription drugs or medical devices to publicly disclose such benefits.
(Filed 1/1/03 and sent to committee on 6/26/03; no action before end of '03 session*)

MI
SB 41
Sen. Hammerstrom

Would require reporting of expenditures by pharmaceutical manufacturers in different categories. Would require that a manufacturer or agent or anyone acting on behalf of a manufacturer or agent could not give a gift to a prescriber.
(Filed 1/22/03 and sent to committee; no action before end of '03 session*)

MN
151.461
(1993)

Prohibits any manufacturer or wholesale drug distributor, or any agent thereof, to offer or give any gift of value to a practitioner over $50. Some exceptions apply.
(Signed into law, 1993)

MN
HF 2184
Rep. Paymar,
SF 2189
Sen. Pappas

Would modify the gift ban for prescription drug practitioners, to cover gifts valued at $20 or more per year, replacing the old $50 standard. Violations would be subject to license revocation and $10,000 fine.
(Filed 2/19/04; SF 2189 favorable report 3/17/04; did not pass by end of regular session 6/04)|

MN
HF 2086
Rep. Paymar
SF 1971
Sen. Titus

Would require manufacturers to report all gifts and marketing activities with anyone that is intended to promote the sale of the manufacturer's drugs. (HF 2086: Filed 2/12/04, did not pass by end of regular session 6/04) (SF 1971: Filed 2/12/04 and sent to committee 3/17/04, did not pass by end of regular session 6/04)

MS
SB 2546

Would create the Pharmaceutical Marketing Disclosure Law; providing for marketing expense reporting by pharmaceutical manufacturers. representatives
(Filed and sent to committee 2/12/04)

NV
SB 387
Sen. Titus

Would require manufacturer of drugs to file a report with the Board disclosing the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit that the manufacturer provided, directly or indirectly, to a practitioner who is located within this state or an administrator of a health care facility or plan that conducts business within this state. (this particular provision stricken before final passage)
(Filed 3/17/03, passed by Senate 4/22/03 and passed Assembly 5/19/03; signed by governor without Rx provision 5/26/03)

NJ
A 69
Brodsky Thompson

Would prohibit a pharmacist from releasing or disclosing the name, address, or telephone number of any individual for whom a prescription drug is dispensed or his agent for use in commercial solicitation without the prior written or electronic consent of that individual.
(Filed 1/8/02 and sent to committee; carried over to 2003 session)

NJ
A 2839
Assm. Hurt
AB 1801 (2004)

Would require pharmaceutical manufacturers to disclose gifts, fees and other economic benefits provided to health care providers for promotional and marketing purposes.
(Filed 10/3/02 and sent to committee; carried over to 2003 session)
(AB 1801: Filed 1/13/04 and sent to committee, did not pass by end of session)

NM
HB 666
Rep. Picraux

Would require a person who manufacturers prescription drugs for sale or consumption in New Mexico to annually report to the New Mexico health policy commission the following: the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit incurred in connection with detailing, promoting or other marketing activities by or in behalf of the company, directly or indirectly, to any physician, hospital, nursing home, pharmacist, health maintenance organization, managed care organization, health insurance or health benefit plan or any other person authorized to prescribe, dispense or purchase prescription drugs in New Mexico. (this particular provision stricken before final passage)
(Passed House 3/03; passed Senate 3/03; signed by governor without Rx provision 4/8/03)|

NM
SB 647
Sen. Hurt

Would require a Maziarz WouldVelella WouldBrodsky Wouldcopayment by the manufacturer of any prescribed drug that is advertised directly to consumers.
(Sent to committee 3/31/03; died at end of session)|

NY
A 674
Brodsky

Would prohibit manufacturers and distributors of prescription drugs from deducting the costs of advertising such drugs to consumers from their income taxes.
(Filed 1/08/03 and sent to committee; carried over to 2004, 1/7/04*)

NY
S 270
A 635
Sen. Velella

Would expose manufacturers of prescription drugs of medical devices who engage in direct to consumer advertising to civil liability where adequate warnings are not provided.
(Filed 1/08/03 and sent to committee; carried over to 2004, 1/7/04*)

NY
S 505
A 3867
Sen. Maziarz

Would require pharmaceutical drug manufacturers and wholesalers to annually disclose all gifts valued over $75 to certain health care practitioners.
(Filed and sent to committee 1/3/03; carried over to 2004; amended in committees 1/22/04*)

NY
A 10343
S 6552

Would require Rx manufacturers which engage in marketing activities in the state to annually report marketing expenses; with a $100,000 civil fine for failure to report.
(Filed and sent to committee; amended 4/8/04)

ND
H 1283
Rep. Kasper

Would prohibit, unless a customer provides express authorization under this section, a pharmacist or pharmacy from disclosing individually identifiable health information to a third party for the purpose of marketing a product or service; or b. Participating in for-profit marketing of a product or service to a customer if the marketing to the customer is based upon identifying customer information.
(Passed House 2/3/03; failed to pass Senate 3/19/03)|

ND
H 1487
Rep. Gulleson

Would allow a health care provider, a pharmacy, a person conducting health research, a health plan, a health oversight agency, a public health authority, an employer, a health or life insurer, or a school or university to provide marketing services to a pharmaceutical company if that health care entity provides clear and conspicuous notice to the individual involved concerning the health care entity's disclosure practices for all individually identifiable health information collected or created with regard to the individual and obtains the consent of the individual involved to use the information and that consent is manifested by an affirmative act in a written communication that only references and applies to the specific marketing purpose for which the information is to be used.
(Filed 1/20/03; failed to pass House 2/18/03)|

OH
SB 123
Sen. Hagan

Would require pharmaceutical drug manufacturers to disclose advertising and promotional expenses to the State Board of Pharmacy and to require the Board to compile the disclosures into an annual report.
(Filed 9/2/03; sent to committee; did not pass by end of '03 session*)

OR
H 3090
Rep. Tomei

Would require pharmaceutical manufacturing companies to disclose certain economic benefits over $25 provided in conjunction with marketing of prescription drugs.
(Filed 3/7/03; did not pass by end of session 8/27/03) |

RI
H 7807
Rep. Kilmartin

Would require drug manufacturers and their marketers to disclose all the gifts that they give to the prescribers or dispensers of prescription drugs. In addition, it would restrict the monetary value of the gifts to $150 per gift and $450 per year to each recipient.
(Filed and sent to committee 2/12/04; did not pass by end of regular session 6/04)|

VT
S. 74
Sen. Bloomer

Would propose to require disclosure of the names of recipients of gifts or other benefits from pharmaceutical marketers.
(Filed 2/11/03; passed Senate 3/27/03 and sent to House committee 3/31/03; no action before end of session)|

VT
H 493
Rep. Koch

Would amend provisions of the Healthy Vermonters pharmacy discount plan; including regulating pharmacy benefit managers; requiring the disclosure of retail prescription drug prices. It would exempt certain mental health drugs from the prior authorization process and assist Medicare beneficiaries with paying drug costs not covered under the federal Medicare drug benefit.
(Filed 12/26/03 and sent to committee 1/6/04; did not pass by end of regular session 5/20/04)|

VT
H. 532
Rep. Martin

Would require public disclosure of prescription drug marketing costs by pharmaceutical manufacturers.
(Filed and sent to committee 1/8/04; did not pass by end of regular session 5/20/04)|

VT
H 638
Rep. Fisher

Would prohibit advertising prescription drugs on broadcast media.
(Filed and sent to committee 1/27/04; did not pass by end of regular session 5/20/04)|

VT
H 713
Rep. Mazur

Would establish the small business health care tax incentive program; creates the health care cost containment council. It would require pharmaceutical marketers to make prescription drug price disclosures and require pharmacy benefit managers to provide supplemental financial quotations which identify sources of revenue.
(Filed and sent to committee 2/3/04; did not pass by end of regular session 5/20/04)|

VT
H 768

FY 2005 Appropriations Act provides:
     (Sec. 128a) Retail pharmacists are required to disclose prescription drug prices to consumers; (Sec 128b) pharmaceutical marketers are required to disclose prescription drug "AWP" prices to health care professionals, and report gifts and marketing expenditures to the Attorney General;
    (Sec. 128d) state pharmaceutical assistance programs are required to provide coverage for over-the-counter drugs listed on the state preferred drug list; pharmacy benefit managers and health insurers are required to permit retail pharmacists to use same prices and quantity as mail-order pharmacies; the state department (PATH) is required to implement an evidence-based research program featuring generics and "counter-detailing", by January 1, 2005. Also contains other Rx provisions unrelated to marketing.
(Passed House and Senate 5/20/04, signed by governor as Act 122, 6/10/04) | Click here for the text and GUIDE TO VERMONT'S PHARMACEUTICAL MARKETING DISCLOSURE LAW

VT
S. 288
Sen. Leddy

Would require "pharmacy benefit managers or health insurers to disclose prescription drug prices to consumers and health care providers"; includes over the counter drugs on the state's preferred drug list (PDL); amends the Healthy Vermonters prescription drug program; requires the licensing of PBM's; provides the office of the attorney general with investigative power under the disclosure laws applicable to pharmaceutical marketers; requires the use of the state's preferred drug list in the state employees' health benefit plan. Also requires a study of "the feasibility of providing discounted prescription drugs to vulnerable patient populations through the use of Section 340B" federal drug discounts. Also would require the state to convene a working group to "develop and implement a plan to include outreach, education, and assistance to minimize confusion and duplication of coverage expected to be caused by the introduction of the new, federally mandated Medicare discount cards", for those who also are eligible for Medicaid, VHAP-Rx, Committee PartPrague WouldSoto Wouldpassed DescriptionClibborn WouldVScript, VScript Expanded, or Healthy Vermonters. Also specifies that the state shall establish a program to describe how residents are able to purchase prescription drugs from Canada, including mail-order options and a state-sponsored website. Would specify that any health insurer "shall cover prescription drugs purchased outside this country on the same terms... as drugs purchased in this country."
(Filed and sent to committee 1/13/04; passed Senate 3/17/04; did not pass by end of regular session 5/20/04) |

WA
H 1399
Rep. Clibborn

Would require disclosure and reporting of gifts, grants, and gratuities made by pharmaceutical manufacturers, directly or indirectly, to any person or entity authorized to prescribe, dispense, or purchase prescription drugs in Washington.
(Filed 1/24/03; did not pass by end of regular session, 4/27/03) |

WV
HB 4084
Del. Michael

West Virginia Pharmaceutical Availability and Affordability Act 1) establishes a state-sponsored clearinghouse for consumer Rx information; 2) establishes a state-sponsored prescription drug discount card program for residents with annual incomes up to 200 percent of federal poverty guideline. The program may use voluntary manufacturer rebates but may not use formularies or preferred drug lists; 3) establishes a state Council that "shall establish a pricing schedule using or referencing the FSS (Federal Supply Schedule) prices", which requires a future, additional legislative vote of approval or rejection. Also provides that the state shall "explore the feasibility of using or referencing, the federal supply schedule or Canadian pricing. 4) requires the state to "investigate the feasibility of purchasing prescription drugs from Canada," including feasibility of serving as a wholesale distributor of prescription drugs in the state." 5) requires reporting of Rx advertising costs.
(filed; passed House 1/22/04; passed Senate and Conference 3/13/04, signed by governor 4/7/04) |
WV Pharmaceutical Cost Management Council -website

* = Legislative rules may allow for continuation or "carryover" to 2004 session.

Examples of 2001-2002 DTCA State Bills and Laws

During the 2001 and 2002 legislative sessions, several states have attempted to legislate different aspects of DTCA, including advertising, marketing, and doctor detailing and counter-detailing. This chart summarizes some of those bills. Generally, this chart does not include proposals that mention DTCA as a "source for a particular problem" or do not attempt to change DTCA practices. For example, proposals that refer to the addictive nature of an advertised drug or an over-the-counter product are not included in this listing, unless they aim to change the way prescription pharmaceuticals are advertised.In 25 states Legislative rules may allow for continuation or "carryover" to 2004 session.

State/bill/ web link

yell ow = passed
Description / excerpts of bill text

(Bill status may change frequently - check state legislatures for most recent actions. In some states special sessions can reconsider bills not passed in a regular session)

CA

SB 1099 ('02)
Sen. Soto
Would provide that "No deduction shall be allowed under the law for specified expenses paid or incurred by pharmaceutical manufacturers to advertise the sale, use or consumption of pharmaceuticals."
(Filed 1/7/02; died in committee, 2/27/02)|

CT

S 39 ('01)
Sen. Prague
Would amended the required statutes and require pharmaceutical companies that provide prescription drugs in this state to disclose all prescription drug advertising and promotional costs to the state and to require the state, through an existing state agency or a newly created cost containment council, to conduct a cost/benefit analysis to determine the impact of such costs on prescription drug prices and the impact on state residents of the additional prices and costs of prescription drugs attributable to advertising and promotional activities.
(Filed 2/7/02; died 5/6/02 at the end of the 2002 session)|

CT

H 5607 ('01)
Human Services Committee
Part of a larger bill; would state, "Any manufacturer of pharmaceuticals which were sold in this state during the preceding year shall file a report with the commissioner of consumer protection... shall disclose the total amount of expenses for advertising and promotions of pharmaceuticals in this state and in the US for the preceding year."
(Filed 1/12/01; died in committee 5/30/01)|

CT

H 6076 ('01)
Rep. Valle
Would "Require all pharmaceutical companies doing business in CT shall provide an annual report ...that discloses aggregate advertising costs and by-category promotional costs expended in CT to market pharmaceuticals to health care providers."
(Filed 1/17/01; died at the end of the 2002 session)|

CT

H 5639 ('02)
Human Services Committee

Would require "By March 31, 2003, manufacturers of prescription drugs sold in Connecticut during the previous calendar year to file an annual report with the Affordable Prescription Drug Board. "The report must disclose aggregate Connecticut-based newspaper, radio, and television advertising and promotional expenses. Promotions include free samples, media events, gifts, trips, conferences, or meals for health care providers whose offices are based in Connecticut." Manufacturers must list expenses for promotions by these and other categories the manufacturers determine appropriate.
(4/26/02, died in committee at the end of the 2002 session)|

HI

HCR 31
SR 12
Rep. Chun
Would allow the Department of Commerce and Consumer Affairs and health insurance providers in the State of Hawaii to work together to create a consumer education program to make consumers aware of the fact that brand name drugs, after their patents have expired, become generic drugs that are equally effective at a reduced cost.
(Filed 2/11/02; died in committee at the end of the 2002 session )|

HI

Signed version: HB 2834
original as filed:
HB 2834 ('02)
Rep. Say
The original House bill and the Senate passed bill contained the following provision, but the language was stricken from the signed final version: Requires manufacturers to report the costs of advertising and marketing prescription drugs in the state. The annual report shall include the following information as it pertains to marketing activities conducted within this state: (1) All costs associated with marketing, advertising, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone communications; and (2) All costs associated with educational programs, seminars, entertainment, trips, remuneration for promoting or participating in informational sessions regarding prescription drugs, product samples of prescription drugs in excess of $10 in value, and promotional gifts in excess of $10 in value. (stricken before signature by the governor.)

The remaining part of the bill was passed: Established the Hawaii Rx discount program, with "all residents of the state eligible to participate," and no age or income limitations. Manufacturers would be asked to voluntarily agree to rebates, and each retail pharmacy voluntarily participating in the Hawaii Rx program would discount the price of drugs covered by the program and sold to program participants.
(see details on discount program)
(Filed 1/25/02; passed House, 2/20/02; amended and passed Senate,4/9/02; final passage and sent to governor, 4/30/02, signed by governor as Act 76, 5/31/02)
Hawaii Rx bills become law - news release June 3, 2002

IL

HR 303 ('01)
Rep. Hoffman, et al.
Would direct the Illinois Health Care Cost Containment Council to conduct a cost/benefit analysis of advertising associated with the provision of prescription drugs to citizens of Illinois by pharmaceutical companies and distributors.
(Filed 5/10/01; died at the end of the 2002 session 7/2/02)|

IL

S 1720 ('02)
Sen. del Valle
Would require any pharmaceutical company that provides prescription drugs in Illinois to disclose to the Council, in a manner and fashion designated by the Council by rule, all prescription drug advertising and promotion costs. The Council must then conduct a cost/benefit analysis to determine (Say Thepassed Kane Would Crall WouldCherry WouldDescriptioni) the impact of these costs on prescription drug prices and (ii) the impact on Illinois residents of any increase of the prices and costs of prescription drugs that is attributable to the advertising and promotional activities.
(Filed 2/05/02, died at end of 2002 session)|

KY

BR 433 ('02)

BR 925(HCR 62) ('01)
Resolution would urge the US Congress, Dept of HHS, FDA to limit, ban or otherwise impose strict standards on DTCA of drugs by pharmaceutical companies. This perhaps effects the physician/patient relationship and quality of care received by patients, and the increasing cost of pharmaceuticals.
(Filed 1/8/02; passed House 93-1 with Committee Substitute; 1/29/02, sent to Senate Judiciary Com.; died at end of 2002 session)|

KY

HCR 7 ('02)
(same as above)
Rep. Cherry
Would urge the United States Congress, Department of Health and Human Services, and Food and Drug Administration to limit, ban, or otherwise impose strict standards on direct-to-consumer advertising of drugs by pharmaceutical companies. (Filed 1/8/02; passed House 93-1 with Committee Substitute; Sent to Senate Judiciary Com. 1/29/02; died at end of 2002 session)|

KY

HCR 36
Rep. Crall
Would urge United States Congress and Department of Health and Human Services to recognize the impact of pharmaceutical direct-to-consumer advertising targeted to the public at large. The General Assembly respectfully requests the United States Congress and Department of Health and Human Services to place a two year moratorium on direct-to-consumer pharmaceutical advertising for the purpose of studying the effect of direct-to-consumer pharmaceutical advertising on patient utilization and on the physician-patient relationship. The Clerk of the House of Representatives is directed to transmit copies of this Resolution to the Secretary of the United States Department of Health and Human Services and to each member of Kentucky's Congressional delegation.
(Filed 1/9/02; died at end of 2002 session)|

ME

HP 778 or LD 1022 ('01)
Rep. Kane
Would require full disclosure of pharmaceutical marketing costs. "A manufacturer, etc. that sells pharmaceuticals in the state shall make available for public inspection all costs associated with marketing the pharmaceuticals including advertising and direct promotion to the physicians including educational programs, samples, and gifts."
(indefinitely postponed 6/11/2001; died at end of session)|

ME

SP 353 or LD 1167
Sen. Treat
"An Act to disclose Prescription Drug Marketing Activities": Would require prescription drug manufacturers, wholesalers and labelers to register persons employed by them to make informational, educational and sales presentations in this State. It requires reports of the average wholesale price of certain drugs, the lowest prices for which those drugs were sold and any rebates or discounts applicable to those drugs. It requires certain disclosures for persons making informational, educational and sales presentations. The bill charges the Bureau of Medical Services within the Department of Human Services with implementing the law and provides for public access to Newman WouldTolman WouldMoore Wouldnonconfidential information and for an annual report. The bill makes a violation of the registration or the disclosure requirements a civil violation enforceable by the Attorney General.
(Referred to Health and Human Services, 2/28/02; died at end of session 05/21/02)|

MA

S1979 ('01) and S547
Sen. Moore
Would affect the collection of data relative to direct to consumer advertising.
(Reported favorably 7/1/0; died at end of 2002 session)|

MA

S.589 ('01)
Sen. Tolman
Would create a Massachusetts Prescription Drug Pricing Review Commission, mandated to "assess on at least a semi-annual basis whether prescription drugs are being sold in the Commonwealth at prices reasonably comparable with the Federal Supply Standard (FSS)". Public reports shall include comparisons of FSS prices to prices of those prescription drugs "found to be sold at excessive profits" in Massachusetts. Manufacturers listed as "profiteering" would be required to report quarterly to the Commission on marketing and promotional expenditures directed to residents of the Commonwealth, including amounts spent on advertising, samples, gifts, salaries, and commissions.
(Filed 1/3/01; placed in inactive study 9/6/01; died at end of 2002 session)|

MT

HB 565 ('01)
Rep. Newman
Would establish interim committee to study purchasing pools for individuals and small group insurance, provider reimbursement rates and cost shifting of health care costs, access to affordable Rx, strategies to decrease the number of uninsured MT, factors causing health insurance rates to increase above the rate of inflation, and any other issue that the committee or staff deem appropriate and relevant to the problem.
(Died in committee, 3/24/01)|

NJ

A 1635 ('02) Godbey

A 3195 ('01) Assm. Cohen
Would affect the distribution of premiums or rebates by pharmacists in connection with the sale of certain drugs. "Advertising of pharmaceuticals in a manner inconsistent with rules and regulations promulgated by the Dir. of Consumer Affairs. Provided, however, no such advertising of any drug or substance shall be authorized unless the Commissioner of Health shall have determined that such advertising is not harmful to public health, safety and welfare.
(Filed 2/5/01, died at end of 2001 session*)|

A 1635- (1/31/02, Introduced; sent to Assembly Health and Human Services Committee.)

NM

HJM 20 ('01)
Rep. Godbey
Would state, "Whereas the cost of pharmaceutical advertising is $1.8B and growing, be it resolved that the US Congress be urged to review and revise the FDA's regulations that permit DTCA of pharmaceuticals, revising them to a stricter interpretation of the previous FDA guidelines or a limitation on such advertising ... Develop regulations that encourage the pharmaceutical industry to promote its products more responsibly, regulate DTCA more effectively and provide guidance for the medical and public health communities to educate the general public about drug therapies and alternatives in more constructive ways."
(Died at end of 2001 session)|

NY

A 6220 ('02)
Murphy
Would amend tax law to eliminate the deductibility for certain expenses incurred in the advertising of prescription drugs. "Expenses incurred buy a manufacturer or distributor of a drug, the dispensing of which to a consumer without a prescription is prohibited by either federal or state law, for the advertising of such drug to consumers."
(Sent to Ways and Means committee, 1/9/02; died at end of 2002 session)|

NY

A 8870 ('02) same as
S 6897
Rules Committee
Would amend public health law, in relation to requiring a cost/benefit analysis of pharmaceutical advertising and promotional expenses. Must disclose aggregate cost of advertising pharmaceuticals in the media in all formats.
(4/11/02, Referred to health; died at end of 2002 session)|

NY

S 3333 ('01)
Sen. Velella
Would amend tax law to eliminate the deductibility for certain expenses incurred in the advertising of prescription drugs. "Expenses incurred buy a manufacturer or distributor of a drug, the dispensing of which to a consumer without a prescription is prohibited by either federal or state law, for the advertising of such drug to consumers."
(Filed and sent to committee 1/9/02; died at end of 2002 session*)

PA

S 127 ('01)
Sen. Murphy
Would state, "Advertising is making the cost of pharmaceuticals go up" therefore the Health Care Cost Containment Council shall conduct a cost/benefit analysis of advertising and promotional activities associated with the provisions of pharmaceuticals to this Commonwealth's citizens by pharmaceutical companies and distributors. Disclose aggregate data of all advertising and promotional costs to the councils. Report back to the general assembly. (1/29/01, Referred to public health and welfare; died at end of 2002 session)|

VT

JRH 18 ('01)
Rep. Mullin and Rep. Shumlin
Would state, "Because of the high costs of pharmaceuticals compared to other countries etc. "Calls upon our congressional delegation to immediately propose and seek passage of legislation that will require any pharmaceutical company which receives or benefits from any federal funding for pharmaceutical research and development to amortize the company's R&D costs over the entire world market for pharmaceuticals. Would also "Pass legislation that will allow free trade of pharmaceuticals between US and Canada, and propose and pass legislation that will restrain the huge expenditures by pharmaceutical companies on advertising and marketing of their products.
(Adopted by House, 1/17/01; died in Senate at the end of 2002 session)

VT
H.31 of 2002
Sen. Shumlin

This multi-featured pharmaceutical law includes:
1) Counterdetailing"- Implements education programs, including a counterdetailing program, designed to provide information and education on the therapeutic and cost-effective utilization of prescription drugs to physicians, pharmacists and other health care professionals authorized to prescribe and dispense prescription drugs;
2) Disclosure of gifts and cash payments to doctors- Annually on or before January 1 of each year, every pharmaceutical manufacturing company shall disclose to the Vermont board of pharmacy the value, nature and purpose of any gift, fee, payment, subsidy or other economic benefit provided in connection with detailing, promotional or other marketing activities by the company, directly or through its pharmaceutical marketers, to any physician, hospital, nursing home, pharmacist, health benefit plan administrator or any other person in Vermont authorized to prescribe, dispense, or purchase prescription drugs in this state. Disclosure shall be made on a form and in a manner prescribed by the board. Initial disclosure shall be made on or before January 1, 2004 for the 12-month period ending June 30, 2003. The board shall provide to the office of the attorney general complete access to the information required to be disclosed under this subsection. The office of the attorney general shall report annually on the disclosures made under this section to the general assembly and the governor on or before March 1.
3) Creates a discount program, preferred drugs and other features - see full description on 2002 Prescription Drug Discount, Bulk Purchasing and Price-Related Legislation
(H 31 House and Senate final passage, 5/31/02; signed by governor, 6/13/02)|

VT

HJR 60 ('01)
Rep. DePoy
Would send a resolution to the FDA to institute a moratorium on DTCA and urging agency to develop more stringent regulatory restrictions on these promotional activities.
(3/13/01 Adopted by House; died in Senate at the end of the 2002 session)

VT

S 131 ('01)
Sen. Bloomer
Part of a larger bill to organize and fund public prescription drug education, Toblin AllowsKiss WouldParlette WouldBloomer WouldRivers WouldShumlin WouldRivers Wouldcountermarketing and substitution strategies to balance the effect of pharmaceutical company marketing behavior.
(Filed 2/22/01; died in committee at end of session) |

VT

S 135 ('01)
Sen. Rivers
Would include the creation of: a "program of academic detailing and consumer counter-detailing that educates physicians and consumers on the therapeutic and cost-effective utilization of prescription drugs, developed in a manner designed to counteract the marketing efforts of pharmaceutical companies directed at physicians, and to counteract direct-to-consumer advertising, and developed in coordination with similar programs administered throughout the state.
(Filed 2/23/01; died in committee at end of session) |

VT

S 170 ('01)
Sen. Shumlin
Would state, "Because a "substantial and significant portion of the pharmaceutical price and cost to the consumer and the state is represented in advertising." The commissioner of prevention, assistance, transition and health access shall conduct a cost/benefit analysis of advertising and promotional activities associated with the provision of prescription drugs to this state's citizens by pharmaceutical companies." Also, would require "disclose in aggregate all advertising expenses associated with pharmaceutical direct-to-consumer advertising."
(Filed 2/27/01; died in committee at end of session) |

VT

S 178 ('01)
Sen. Rivers
Would highlight "cost effective pharmaceutical prescribing practices and counter marketing to DTCA". Also addressed Federally Qualified Health Centers, and the V-SCRIPT pharmaceutical program.
(Filed 2/27/01, died in committee at end of session) |

VT

S 231 ('02)
Sen. Bloomer
Would direct the state to implement a prescription drug counter-detailing program.
(Filed 1/10/02; died in committee at end of session) |

WA

S 5960
Sen. Parlette
Would state, "The intent of the Legislature to create an exception to the learned intermediary doctrine for prescription products advertised directly to consumers is stated. The manufacturer of a prescription product that is advertised directly to consumers in this state, who would otherwise be liable for harm caused by the product, is not relieved of that liability solely because the manufacturer warned the practitioner who prescribed the product of its proper use and attendant dangers."
(Filed 2/9/01; reintroduced 1/14/02, did not pass by end of 2002 session)|

WV

H 2538 ('02)
Speaker Kiss
Would require DTCA of any pharmaceutical to include the usual and customary price of the drug.
(Sent to House GO committee, 1/9/02; died at end of session)|

WV

S 127 ('01)
Senate Pres. Toblin
Allows WV Public Employees Insurance Agency to pursue a multi-state buying pool with all state agencies and institutions, as well as "governments of other states and jurisdictions, and "regional or multistate purchasing alliances". Allows "innovative strategies", such as "enacting fair prescription drug pricing policies" and providing discount prices or rebate programs for seniors" and uninsured. The agency may explore "requiring prescription drug manufacturers to disclose to the state expenditures for advertising, marketing and promotion, as well as for provider incentives and research and development efforts."   PEIA director's description.
(Passed House and Senate; signed by Governor 5/15/01 as Chapter 97)

WI

AB 750 ('01)
Rep. Schneider
Would prohibit any person who manufactures or distributes prescription drugs (manufacturer) in this state from giving, or offering to give, anything of monetary value to any practitioner to encourage the practitioner to issue prescriptions for that manufacturer's drugs. Current law defines a practitioner to mean any person who is licensed in this state to prescribe and administer drugs or who is licensed in another state and recognized by this state to prescribe and administer drugs. The prohibition created under the bill does not apply to gifts given or offers made by a manufacturer to a practitioner who is a relative of that manufacturer or to product samples given by a manufacturer to a practitioner for delivery to a patient.
(Filed 1/28/02; sent to committee 3/26/02, died at end of session)|

* Bills may be subject to continuation or "carryover" from 2001 to 2002.

Additional References and Sources

Government Reports

GAO Report: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising (November 2006)
The Food and Drug Administration (FDA) is responsible for overseeing direct-to-consumer (DTC) advertising of prescription drugs. If FDA identifies a violation of laws or regulations in a DTC advertising material, the agency may issue a regulatory letter asking the drug company to take specific actions. GAO was asked to discuss (1) trends in drug company spending on DTC advertising and other activities; (2) what is known about the relationship between DTC advertising and drug spending and utilization; (3) the DTC advertising materials FDA reviews; (4) the number of regulatory letters that cited DTC materials and FDA's process for issuing those letters; and (5) the effectiveness of these letters at limiting the dissemination of violative DTC advertising. GAO reviewed research literature, analyzed FDA's processes, and examined FDA documentation. http://www.gao.gov/new.items/d0754.pdf

Department of Health & Human Services- Report to the President Prescription Drug Coverage, Spending, Utilization, and Prices, April 2000 http://aspe.hhs.gov/health/reports/drugstudy/index.htm

Food and Drug Administration- New FDA Draft Guidances Aim to Improve Health Information- February 4, 2004
FDA Releases Preliminary Results of Physician Survey on Direct-to-Consumer Rx Drug Advertisements- Jan. 13, 2003
Direct to You: TV Drug Ads That Make Sense http://www.fda.gov/cder/about/whatwedo/testtube-11.pdf

Pharmaceutical Industry Reports
Pharmaceutical Research and Manufacturers of America (PhRMA)- Draft DTC Voluntary Guidelines, press release from July 22, 2005.
http://www.phrma.org/mediaroom/press/releases/21.07.2005.1193.cfm

Pharmaceutical Research and Manufacturers of America (PhRMA)- Overview of d

American Enterprise Institute for Public Policy Research: Public Policy Issues in Direct-to-Consumer Advertising of Prescription Drugs

Health Affairs- Forum on Prescription Drug Promotion: ABSTRACT: Spending on prescription drugs and promotion by the pharmaceutical industry grew substantially during the past ten years. Does the greater exposure offered by promotion fill a needed educational gap, or does it merely promote inappropriate use? This paper uses two recent studies to explore this question, presenting a framework in which the impact of promotion depends upon the level of evidence and consensus on drug use. The survey is accompanied by five perspectives debating the pros and cons of direct-to-consumer drug advertising. (Full report can be read at: www.healthaffairs.org/WebExclusives/Pharma_Web_Excl_022603.htm.)

National Conference of Insurance Legislators: NCOIL Report of Direct-to-consumer advertising, April 2002 or http://www.ncoil.org/news/DTCAds.doc

Boston University School of Public Health: Reports- Prescription drug reform and industry analysis. http://dcc2.bumc.bu.edu/hs/ushealthreform.htm

Public Citizen's Health Research Group - To find publications regarding direct-to-consumer advertising, use the search feature on this page using keywords like, pharmaceuticals, advertising, direct-to-consumer: http://www.publiccitizen.org/publications/

Families USA- A variety of pharmaceutical cost reports and opinion pieces: http://www.familiesusa.org/site/PageServer?pagename=Prescription_Drugs_Index

Press

Health Affairs- Forum on Prescription Drug Promotion. February 26, 2003- ABSTRACT: Spending on prescription drugs and promotion by the pharmaceutical industry grew substantially during the past ten years. Does the greater exposure offered by promotion fill a needed educational gap, or does it merely promote inappropriate use? This paper uses two recent studies to explore this question, presenting a framework in which the impact of promotion depends upon the level of evidence and consensus on drug use. . The survey is accompanied by five perspectives debating the pros and cons of direct-to-consumer drug advertising. (Full report can be read at: www.healthaffairs.org/WebExclusives/Pharma_Web_Excl_022603.htm.)

New GAO Report Affirms Pharmaceutical Company Spending On Research For New Medicines and Cures Far Outpaces Promotional Spending - December 5, 2002 - (Link to press release provided by PhRMA) Link to GAO Report # 03-117

Prozac-in-the mail incident highlights drug companies' aggressive tactics August 6, 2002- The Associated Press

The Fight to Keep 'Direct-to-Consumer Ads' - July 12, 2002- New York Times

March 14, 2002-
FDA Is Inundated Trying To Assess Drug Ad Pitches
By CHRIS ADAMS- Staff Reporter of (c) THE WALL STREET JOURNAL

ROCKVILLE, Md. -- In the escalating drug-advertising battle, Thomas Abrams is the referee.

As director of the Division of Drug Marketing, Advertising and Communications for the Food and Drug Administration, Mr. Abrams is charged with ensuring that drug ads and sales pitches are fair, balanced and truthful. But it's become overwhelming trying to assess them all.

From 1996 through 2001, the number of ads submitted annually for FDA scrutiny, including television spots, magazine ads, Internet sites, even poster boards and pamphlets used by sales representatives, jumped nearly 35%, to more than 34,000 from 25,236. Yet the FDA has issued fewer citation letters to drug makers alleging that ads or marketing materials were false, misleading, or otherwise out of compliance, a review of FDA records shows.

After FDA officials sent out more than 150 citation letters in 1996, 1997 and 1998, the number steadily decreased, hitting 71 in 2001.

Drug makers say the drop in citations shows that the advertisements are cleaner than before. A spokeswoman for Pharmaceutical Research and Manufacturers of America, the industry's main trade group, says the companies are "much more knowledgeable" about what is within FDA rules today than they were in 1997, when new federal guidance opened the door for the flood of ads now on TV. The FDA's Mr. Abrams says: "We don't measure our success in terms of the number of enforcement measures we take."

Indeed, Mr. Abrams says that with the division's "limited resources" his staff couldn't possibly dig into every ad even if he wanted to. In 1996 there were the equivalent of 28 full-time workers on his staff; in 2001, there were 30. In addition, many of the marketing pitches have gotten increasingly sophisticated and complicated, while monitoring them has become more difficult as companies use new technologies like hand-held computers to deliver their messages.

So, he and his team focus on the ads deemed most critical -- those that appear on television, make unusual claims or raise a major public health issue. Reviewing a one-page ad in a medical journal, for example, is relatively straightforward, Mr. Abrams says. But catching drug sales representatives spinning tales or playing down a drug's risks during a sales call is tougher. "You have to be sure what was said before you make any conclusions or allegations," Mr. Abrams says.

Promotions for Merck & Co.'s blockbuster arthritis drug Vioxx illustrate how complex the FDA's ad-watching duties can be. In June 2000, a physician held a series of audio conference calls on Merck's behalf to tout the drug. At the time, Vioxx was under scrutiny because a study had suggested that patients using Vioxx had a higher rate of heart attacks than patients who received an older drug, naproxen. One possibility was that naproxen helped reduce heart attacks, but the Merck speaker neglected to discuss another possibility: that Vioxx might have been a cause of the attacks.

But later, the FDA caught Merck painting a similarly rosy picture about Vioxx's cardiovascular profile in other forums, including a May 2001 press release and during two out-of-the-way medical conferences. Finally, after more than a year of monitoring, the FDA in September sent a warning letter -- its most serious type of citation -- to Merck citing the "seriousness of these violations," and requested that Merck cease all such messages and prepare a corrective statement. Says a spokesman for Merck: "We saw the issue; we corrected it quickly." The company says it sent letters elaborating about possible heart troubles from Vioxx to 100 doctors and 2,000 pharmacists who may have had heard the previous messages.

In some cases, companies seem to push the limits until told to stop. On May 12, 2001, a FDA ad-watcher attended an oncologists' meeting in San Francisco. While watching and listening to the drug sales representatives working exhibit hall booths, the official observed a pitch on behalf of Maxim Pharmaceuticals Inc.'s proposed drug Ceplene, which is being tested for treatment of melanoma, leukemia and hepatitis. According to a citation letter the FDA later sent Maxim, the sales rep made repeated statements touting the drug as safe and effective even though it had yet to be approved -- a violation of FDA rules. The rep boasted: "Phase III studies are showing a doubling of survival. ... Pharmaceutical IPharmaceutical I would love to tell you more but I can't in case you're with the FDA."

The FDA requested that Maxim's sales reps immediately cease such promotional statements, and Maxim said they would, according to FDA records. Despite its various monitoring efforts, such slaps on the wrist are about all the FDA ever issues for infractions. That leads critics of the FDA to counter that the agency is unwilling to take on the powerful drug industry. Sidney Wolfe, director of Public Citizen's Health Research Group, a Washington-based watchdog organization, argues that the marketing pitches aren't any more honest or balanced than in the past. He and consumer and insurance groups say the FDA should beef up Mr. Abrams' division, as well as give it authority to levy stiff fines for companies that repeatedly violate advertising guidelines.

The FDA's Mr. Abrams responds: "I think we're doing a very effective job, I really do. ... If we had more resources, we would do more."

Disclaimer: NCSL is not responsible for information or opinions contained in internet links to web sites outside this organization. NCSL does not provide advice to consumers seeking to participate in state-based programs. For state-specific details, please use the contact telephone numbers provided on the State Pharmaceutical Assistance Programs web report by NCSL. NCSL takes no position for or against state health legislation.

Compiled by Karmen Hanson, NCSL Health Care Program- Denver

Denver Office
Tel: 303-364-7700 | Fax: 303-364-7800 | 7700 East First Place | Denver, CO 80230

Washington Office
Tel: 202-624-5400 | Fax: 202-737-1069 | 444 North Capitol Street, N.W., Suite 515 | Washington, D.C. 20001

Marketing and Direct-to-Consumer Advertising (DTCA) of Pharmaceuticals

For more recent DTCA and Disclosure Related State Bills and Laws - Please see http://www.ncsl.org/programs/health/drugbill07.htm and http://www.ncsl.org/programs/health/drugbill08.htm.

Examples of 2005-2007 DTCA and Disclosure Related State Bills and Laws- Updated through January 2007. For 2007 legislation click here. For 2008 legislation click here.

Examples of 2003-2004 DTCA and Related State Bills and Laws- Updated as needed

Additional References and Sources