PHARMACEUTICALS: Facts, Policies and NCSL Resources
Updated: April 2013
AT A GLANCE: Prescription drugs continue as one of the more active health policy issues in 2013. NCSL has followed the state aspects of these issues for a number of years.
As reported in 2012, Americans spend more than $271 billion dollars on prescription medicines annually. Total spending on drug therapy total about $300 billion dollars, including over-the-counter (OTC) drug remedies,valued at 31 billion.
Back in 2007, CMS researchers predicted that prescription drug spending would grow at an average annual rate of 8.6 percent until 2016. However, for 2007, actual annual growth in drug spending slowed drastically. A federally sponsored annual study documented annual growth of prescription drug spending at 2.9 percent, lower than any other major health care sector and the lowest level in 45 years. Another study led by IMS Health showed growth had dropped to only 3.8 percent for the commercial market for medications.
For 2010, total US retail spending on prescription drugs accounted for the third-largest share—10 percent— of total national health spending, after hospital spending and spending on physician and clinical services. In 2010, total retail prescription drug spending grew only 1.2 percent,
to $259.1 billion. This historically low rate of growth in 2010 was driven by slower growth in the volume of drugs consumed, a continuing increase in the use of generic medications, the loss of patent protection for certain brand-name drugs, fewer new drug introductions than in previous years,20 and an increase in Medicaid prescription drug rebates. The volume of prescription medicines consumed increased at a historically low rate in 2010, with slower or declining demand recorded in nearly every major therapy area.23 The number of prescriptions dispensed increased only 1.2 percent in 2010—a deceleration from 2.1 percent in 2009. The generic dispensing rate (excluding the category of “branded generics”), increased from 66 percent in 2009 to 67 percent in
2010. (CMS Office of the Actuary, Health Affairs, January 11, 2012).
In the dozen years between 2001 and 2012, at least 38 states had passed some type of state pharmaceutical assistance law and four others had executive agency initiatives, for a total of 42 states with assistance programs enacted or authorized. 2 However, the number of operating programs is on the decline, due to Medicare Part D benefits and expanded discounts available under the Affordable Care Act, starting in 2011. Most use state funds to help pay for a portion of the cost of pharmaceuticals for eligible residents who meet age and income criteria. Some states also have established cost-sharing features including co-payments, annual enrollment fees, or monthly limits.
Other states are operating or authorizing broader discount programs aimed at assisting people lacking private insurance, or even the general consuming public. In separate actions, all 50 states have adjusted Medicaid pharmaceutical policy in the past decade. NCSL now has more than 40 reports and presentations on pharmaceuticals, most of which are online and summarized below.
RECENT NCSL MATERIALS & ACTIVITY:
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Compounding Interest: A tragedy caused by contaminated steroids turned the spotlight on compounding pharmacies - Health Program article in State Legislatures Magazine, June 2013
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State Pharmaceutical Assistance Programs - features tables summarizing all current and recent historical state subsidy (SPAP) and discount programs, for seniors, disabled, uninsured and others. Updated periodically; 2012. [22 pages] .
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State Regulation of Compounding Pharmacies - NCSL report, updated 3/2013.
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Health Care Reform: A Pharmaceutical Perspective on State Responses - Slide presentation by NCSL, February 2013.
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Medicaid Preferred Drug Lists (PDLs) for Mental Health and Substance Abuse - new research 50-state summary by NCSL, posted April 2012.
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Use of Generic Prescription Drugs and Brand-Name Discounts - - PDF File - Published by NCSL, June 2010
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Prescription Drug Agreements and Volume Purchasing (Preferred Drug Lists, Rebates, Multi-state Purchasing and Effectiveness Review of Medicine) - PDF File - Published by NCSL, June 2010.
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Resources for Prescription Drugs. Part of the NCSL's Health Cost Containment and Efficiencies series, updated 2012.
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2009 Prescription Drug Enacted State Laws - NCSL's most recent archive report on 84 signed Rx laws in 32 states. January 2010
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Comparative Effectiveness: Better Care or Rationing session at NCSL Legislative Summit, July 2009.
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Prescription Drug Costs Slow - Health Program article in State Legislatures Magazine, April 2009.
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STATE RX LEGISLATION ARCHIVE:
PRESCRIPTION DRUG STATE LEGISLATION - Each year between 1999 and 2009 NCSL compiled and published the most comprehensive tracking report of bills and resolutions affecting pharmaceuticals. The reports are updated including final outcomes at the end of each calendar and session year. These annual reports are offline, but are available upon request. Reports for 2010-2012 are not available in published form.
NCSL ON-LINE REPORTS & PRESENTATIONS:
These web documents include information on laws and initiatives to provide state subsidies, as well as discounts, bulk purchasing, price regulation and other regulatory and funding policies, including state Medicaid and Medicare activities:
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An Introduction to Biologic Medicines - A program for health staff, focused on both science and policy issues related to biologic medicines, and how they fit in the spectrum of medical and pharmaceutical treatments. The program included a welcome from Texas Senator Leticia Van de Putte, a pharmacist for more than 31 years who represents a large portion of San Antonio. Geoffrey Eich, of Amgenl provided programmatic information. Held August 7, 2011
Speakers:
Senator Leticia Van de Putte, former President of NCSL (2006-07), San Antonio, Texas
Geoffrey Eich, an executive director at Amgen, California - Powerpoint ( PDF file-10 pages)
This program was made possible by Amgen, with funding through NCSL’s Foundation for State Legislatures, facilitated by the NCSL Health Program.
Additional Resource:
Regulations for Biosimilars: As biologic drug patents begin to expire, generic versions will hit the market—but how will they be regulated? The Scientist, June 2012
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Generic Drug Pricing and States: $4 drug promotions - NCSL report, updated March 2011.
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Marketing Drugs: Debating the Real Cost - Concern about close ties between doctors and pharmaceutical firms are prompting new financial disclosure laws and education efforts. By Rachel Brand, in State Legislatures Magazine, September 2008.
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Prevention of Prescription Drug/Pharmaceutical Overdose and Abuse - January 2009
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Medicare Prescription Drug Coverage: NCSL Tools for State Legislatures - NCSL overview, updated 2011.
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"Part D Decisions" - Like other employers, many states are collecting a new federal subsidy for maintaining retiree drug coverage--but for most, that's not their final answer. - State Legislatures Magazine, 9/06
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Medicaid Prescription Drug Reform Provisions (DRA) - NCSL 's federal policy has urged congress to amend federal Medicaid law to give states greater flexibility in administering their individual state programs. A Department of Health and Human Services (HHS) Office of the Inspector General (OIG) Document: Determining Average Manufacturer Prices for Prescription Drugs Under the Deficit Reduction Act of 2005 (67 page pdf document).
HHS OIG Document: Review of 340B Prices (52 page pdf document), 5/2/07. Updated 3/08.
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Prescription Drug Bulk Purchasing- material on state initiatives, both multi-state and inter-agency. Updated 2011.
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State Prescription Drug Return, Reuse and Recycling Laws" - newly published by NCSL, updated 1/09.
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"Condition-specific Drug Substitution Legislation: Epilepsy" - Updated 2/09.
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"E-PRESCRIBING: MISSIVES FROM THE FRONT" - New Hampshire, Mississippi and Florida are just three of the states that are seeking to prevent medical errors by expanding the use of e-prescribing. 1/08.
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States and the 340B Drug Pricing Program - NCSL resource report, updated 2010
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Marketing and Direct-to-Consumer Advertising of Pharmaceuticals, 2001-08 - an NCSL report and chart of state legislation, updated 2009.
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"Medication-Assisted Treatment for Opiate Addiction" (MAT) - published by NCSL's DC staff, for 2008.
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Price Disclosure Laws and Websites for Prescription Drugs - a section of NCSL's Disclosure and Transparency of Health and Hostpital Prices - 2009
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Prescription drug emergency controls, scams and hoarding - This report analyzes retail, wholesale and Internet purchases and potential fraudulent, counterfeit or illegal transactions, with a special flu vaccine update. Updated 2009.
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Prescription Drug Monitoring Programs - NCSL resources compiled by the Criminal Justice Program & Health Program, 2008.
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NCSL session on Pharmaceuticals:
IDEAS AT WORK FOR PRESCRIPTION DRUGS held Wednesday, July 23, 2008
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Hear about three programs that are up and running in a growing number of states.
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Prescription Drug Monitoring Programs help medical professionals prevent misuse and abusers from obtaining prescriptions fraudulently before the police knock on the door.
> Speaker: Sherry Green, National Alliance for Model State Drug Laws, Alexandria, VA. - [ Handout#1 | Handout #2]
> Alan Must, Purdue-Pharma, New Jersey - [ Presentation]
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The federal 340B Drug Pricing Program helps over 13,000 qualified health centers, clinics and hospitals provide comprehensive pharmacy services for over 10 million patients.
> Speaker: Lisa Scholz, HRSA Pharmacy Services Support Center, Washington, DC. - [ Presentation]
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Medication Therapy Management (MTM) programs allow pharmacists to provide in-depth counseling to insure that patients get the full benefit of chronic prescribed drugs.
> Edward Staffa, RPh, Vice President, Mirixa & NCPA spokesperson.
> Marjorie Powell, Senior Assistant General Counsel, PhRMA, Washington, DC.
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Achieving Pharmaceutical Access: The Roles of Disclosure and Privacy - RX at NCSL's Annual Meeting in Boston:- August 6, 2007 hosted by the Health Committee. Most Americans rely on the private market for their medicines. This session will examine two hotly-debated prescription drug policies facing states and pharmacists. First, should prescription records identifying doctors or patients be available for marketing purposes by industry professionals? Second, should states set standards for Pharmacy Benefit Managers (PBMs), the middlemen that negotiate prices and transactions for 200 million Americans
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Welcome/Introduction: Senator Leticia Van de Putte, Texas Senate; NCSL President
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Presiding: Senator Durell Peaden, Florida; Vice-Chair, NCSL Health Committee
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Donna Boswell, Hogan & Hartson, Washington DC | PowerPoint
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Representative Cindy Rosenwald, New Hampshire; Chair, NH Health and Human Services Committee | PowerPoint
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Barbara Levy, Pharmaceutical Care Management Association (PCMA) | PowerPoint
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Mark Riley, Vice President, National Community Pharmacists Association (NCPA), Arkansas | PowerPoint
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"POINT-COUNTER POINT: SHOULD STATES REGULATE DATA MINING?" - a transcript excerpt from the session, published in State Health Notes - 9/4/07.
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Update on State Actions Related to Medicare Part D Prescription Drug Coverage, Rx Sessions at NCSL Fall Forum in San Antonio, Texas - December 7, 2006.
On January 1, 2007, the second year of Medicare pharmaceutical benefits begins. Many states continue to play a significant role for seniors and persons with disabilities needing medicines - by providing "wrap around" subsidies for premiums and coverage gaps, by problem-solving and by sponsoring programs for those not eligible for Medicare. New commercial plan designs, questions about state "clawback" payments, Medicaid program responses and possible actions in Congress all loom as legislators prepare to tackle state pharmaceutical budgets and policy. Hear four experts share the latest news and trends.
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Steven McAdoo, Deputy Regional Administrator, Centers for Medicare and Medicaid Services (CMS Region 6), Dallas, Texas | PowerPoint [3.8 Mb]
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Joy Johnson Wilson, Health Policy Director, NCSL staff, Washington, DC
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Richard Cauchi, Health Program Director, NCSL Staff, Colorado | PowerPoint PDF
> "Are our Drugs Safe Enough? A look at Counterfeits, Unapproved Products and Prescribing without Mistakes
International and domestic prescription drug counterfeiting has become a visible policy issue, as suspect copies of drug products have been increasingly confiscated by the FDA. At the same time, consumers read that "hundreds of unapproved drugs made in the US are sold by prescription." Learn what some states are doing, from requiring wholesale product "pedigrees" to demanding legible records, to assure that pharmaceuticals are both safe and accessible.
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Annual Meeting Rx Sessions - held August 16, 2006 in Nashville, TN.
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"Medicare Prescription Drug Coverage and the States" - Even with the Medicare Part D Program well underway, states continue to play important roles in prescription drug coverage for millions of low-income people. In addition to supplementing the new federal coverage, many states are modifying their State Pharmaceutical Assistance Programs and making adjustments to Medicaid and other Rx programs.
* Vernon Smith, Principal, Health Management Associates, Lansing, Michigan PowerPoint Online | html
* Assemblymember Richard Gottfried, Chair, Assembly Health Committee, New York State
* Gloria Parker, Associate Regional Administrator, Centers for Medicare and Medicaid Services, Region Four, Atlanta, Georgia PowerPoint
* Edward Belkin, VP for Communications and Public Affairs, Pharmaceutical Research and Manufacturers of America, D.C. PowerPoint
* Moderator: Senator Judy Lee, North Dakota
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"Prescription Drug Discounts: from 340B to Consumer Cards." - For the 40+ million Americans not on Medicare or comprehensive private insurance, access to prescription drugs remains a visible concern. The federal 340B drug discount program provides one significant option - including a fast-expanding network of clinics and pharmacies in every state. In addition, user-friendly industry-sponsored assistance cards and new state discount laws keep pharmaceuticals near the top of policymakers' priority lists.
* Harry Hagel, Senior Director, HRSA Pharmacy Services Support Center, Washington, DC PowerPoint
* Roba Whiteley, Executive Director, Together Rx Access, Alexandria, Virginia PowerPoint | html
* Moderator: Senator Renee Unterman, Georgia.
MMA- MEDICARE MODERNIZATION ACT:
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Medicare Part D: Latest State Updates NCSL SPRING FORUM- RX Session: held Friday, April 7, 2006 in Washington DC. As part of their ongoing efforts to help Medicare beneficiaries understand Part D, states often are reshaping or creating State Pharmaceutical Assistance Programs to provide additional wrap-around support for Part D enrollees. States are looking at Part D's impact on Medicaid prescription drug programs, including preferred drug lists and rebates. Learn about current state legislative activity on prescription drugs related to Part D and hear from the federal government about key implementation issues affecting states.
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Speakers:
* Joseph Fine and Cora Tracy, [PowerPoint] - Centers for Medicare and Medicaid Services, Baltimore, MD.
* Richard Cauchi and Donna Folkemer, [PowerPoint] - NCSL staff Directors, Denver and Washington, DC.
ARCHIVE: More NCSL Reports 2003-2005
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Frequently Asked Questions: Prescription Drugs - Published by the NCSL Forum for State Health Policy Leadership, spring 2005.
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States and the Medicare Pharmaceutical Law: Resources for State Policymakers. A quick compendium of NCSL-related resources including PowerPoint presentations, audio transcripts and related reports. Updated regularly.
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NCSL Federal Affairs Resources regarding the MMA prepared by NCSL and CMS, updated regularly.
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NCSL Summary of MMA, updated 12/04 -prepared by NCSL Federal Affairs Counsel. see Federal Register 1/28/05.
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MMA: Part D and SPAPs. PowerPoint slides by CMS staff member Marge Watchorn, Pharmacy Division, for NCSL audio-conference, 2/14/05.
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2004 State Pharmaceuticals: Medicare State Adjustment Legislation- by NCSL, 1/05.
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Medicare Pharmaceuticals: Three Weeks to D-Day NCSL's FALL FORUM, CHICAGO IL - December 8, 2005
With Medicare Part D benefits and requirements about to affect tens of millions of Medicare beneficiaries, learn about the latest plans and implementation steps from hands-on experts. The session covered updates on resources and policies from CMS, and examples of state responses and activities.
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Presenters: Peter Leonis, Intergovernmental Affairs Specialist Centers for Medicare and Medicaid Services (CMS) Chicago Region V Office
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Scott McKibbin, State of Illinois Special Advisor for Prescription Drugs
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Senator Judy Lee, North Dakota Senate [PowerPoint]
New State Laws on Rx Promotional Spending Limits and Price Disclosures. PowerPoint slides by Karmen Hanson, NCSL staff, 1/26/05.
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Rx presentations at NCSL 2005 Annual Meeting in Seattle, Washington, August 18:
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Achieving Access to Prescription Drugs: Changing Roles for the States,
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Carol Crimi, MMA, Centers for Medicare and Medicaid Services [PowerPoint]
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Thomas Snedden, Executive Director, PACE Program, [PowerPoint]
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Chiquita White, Manager, Medicaid Practice, Avalere Health [PowerPoint]
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Science and Money: Biomedical Research and Economic Development,
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Patrick Kelly, VP, Biotechnology Industry Organization (BIO) [PowerPoint]
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Prescription Drugs: Issues for the States in 2005 - PowerPoint slides by Donna Folkemer, NCSL staff for Governing Magazine, 2/2/05.
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NCSL Health Conference features Medicare Rx law updates (December 8, 2004):
> Medicare Part D and Implications for Medicaid - opening plenary by Donna Boswell.
> Impact of Medicare law on States as Employers and Plan Sponsors - by Derek Guyton & Jean Schumacher - Mercer Human Resources Consulting. [pdf format]
> NCSL Resolution Adopted by the Task Force on Medicaid from the Fall Forum of the NCSL Standing Committees, December 10 2004, Savannah, Georgia. Includes NCSL action comments on dual-eligibles and the "clawback" payments within the Medicare Modernization Act.
> Medicare, Medicaid and the Role of the States (part 1) by Donna Folkemer.
> Medicare, Medicaid and the Role of the States (part 2) by Richard Cauchi. PowerPoint from NCSL Health Chairs 12/7/04. [pdf format]
What's the Benefit?" - States and the Medicare Law. Article in State Legislatures Magazine July/August 2004. (NCSL Members-Requires password)
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Medicaid:
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Prescription Drug Abuse, [link updated 4/09]
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50 State Summary of Emergency Contraception Laws- compiled by NCSL Maternal and Child Health Project, [link updated 4/09]
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NCSL-NGA Web-assisted Audioconference on "States and the New Medicare Rx Act", a 5-part series. Slides and Transcript from the sessions.
Non-NCSL Resources:
Prescription Drug Resources for 2013 - A selection of additional reports from government, academic, industry and consumer sources, including 50+ direct web links, updated regularly.
Note: NCSL provides links to other Web sites for information purposes only. Providing these links does not indicate NCSL's support or endorsement of the site.
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