AFI Health Committee: ISSUES IN BRIEF
August 1, 2000
Chair:
Representative Kathryn Bowers, Tennessee
Vice Chairs:
Representative Garnet Coleman, Texas
Representative Mary McGratton, Connecticut
Senator Patricia Miller, Indiana
Regulation of On-line Pharmacy
The surge of the Internet is reflected in every aspect of today's economy, including the purchasing of prescription drugs. The advent of on-line pharmacies provides people who are unable to reach a pharmacy on a regular basis or live in rural areas convenient access to pharmaceuticals. The drugs purchased over the Internet are often offered at a discount from regular market price and are therefore more affordable for many people.
Many safety concerns have arisen with the popularity of on-line pharmacies, including: no physician interaction, adverse side effects, dangerous drug interactions, risk of receiving outdated or contaminated drugs. Some on-line pharmacies are conducting sales in states where they are not licensed.
On-line pharmacies create concerns and opportunities for pharmacies, pharmacists and physicians. A major issue for these health care providers concerns licensure. Physicians writing prescriptions in a state where they are not licensed constitutes the illegal practice of medicine. Pharmacists and pharmacies must also be licensed in each state they practice and are subject to the laws of each of those states.
In addition to the many on-line pharmacy sites based from the United States, there is a growing number of Internet pharmacy sites based in other countries. While it is possible to place some regulation on domestic websites, i.e. licensure, states have no authority or jurisdiction over international sites. States do not have the resources to regulate or monitor these international websites.
Last year Representative Ron Klink (D-Pennsylvania) introduced H.R. 2763, the Internet Pharmacy Consumer Protection Act. The bill would amend the Federal Food, Drug and Cosmetic Act by requiring Internet sites to disclose certain information related to which states the employed health care professionals hold license. The legislation would also give states primary enforcement authority over any violations of the act.
President Clinton sent a legislative proposal to Congress on May 2, 2000 (see below). The Congress has been somewhat critical of the Administration's proposal citing its weakness in addressing the problem of international on-line pharmacy sites.
- Preemption of State Law and Regulation
States have traditionally regulated pharmacists, physicians and the operation of pharmacies and have the resources for licensing and disciplining health care professionals on a timely basis. The federal government does not have these resources. Federal proposals that would interfere with states' traditional role in these areas would be of concern.
- Regulation of International Sites
The Drug Enforcement Agency (DEA), the Food and Drug Administration (FDA) and the Office of Customs have been working together to combat rogue international on-line pharmacies. Stopping international sites from illegally selling drugs over the Internet is particularly challenging because cooperation is needed from the host country's government.
As more states prosecute and shut down illegal on-line pharmacies, it is likely that the number of sites hosted outside the United States will increase. State governments have no authority to regulate these sites and will have to work closely with the federal government to reduce the number of illegal international sites selling prescription drugs over the Internet to United States citizens.
The FDA began issuing "cyber" letters during the beginning of 2000 to at least a dozen operators of foreign-based Internet sites that sell prescription drugs in the United States. The letters warn the Internet operators that they are engaged in illegal activities. The FDA also sends a copy of the letter to the U.S. Customs Service and to regulatory officials in the foreign country that the website is based.1 http://www.fda.gov/bbs/topics/ANSWERS/ANS01001.html
Federal Initiatives
The White House
- The Administration sent Speaker Dennis Hastert, the "Internet Prescription Drug Sales Act of 2000," on May 2, 2000. The proposed legislation continues the States role in regulating the practices of medicine and pharmacy while strengthening the federal authority to monitor multistate and interstate issues related to on-line pharmacies. The bill requires on-line pharmacies to be licensed in each State in which they operate or deliver prescription drugs. The legislation would also require each on-line pharmacy to provide the Secretary and relevant state pharmacy boards notification prior to starting a web site. Lastly, the bill allows States to bring civil actions against on-line pharmacies for violations of any of the requirements in federal court.
- President Clinton included new initiatives to protect consumers buying prescription drugs over the Internet in the proposed fiscal year 2001 budget.
- The initiative was originally announced on December 28, 1999. http://www.pub.whitehouse.gov/uri-res/I2R?urn:pdi://oma.eop.gov.us/1999/12/28/2.text.1
- On August 5, 1999 President Clinton issued Executive Order 13,133-Working Group on Unlawful Conduct on the Internet. The working group was required to study several uses of the Internet, including illegal sales of guns, explosives, controlled substances, and prescription drugs, as well as fraud and child pornography. (See Federal Agency Activities Below)
The Congress
Federal Agency Activities
- In July 1999, the Food and Drug Administration announced new efforts to curb illegal on-line pharmacies. The FDA will upgrade its monitoring of such sites, partner with other federal and state agencies to help enforce laws related to on-line pharmacies, and do public outreach to forewarn consumers about health risks associated with buying prescriptions from on-line pharmacies. http://www.fda.gov/bbs/topics/NEWS/NEW00686.html
- The Department of Justice issued a report, "The Electronic Frontier: The Challenge of Unlawful Conduct Involving the Use of the Internet," on March 9, 2000.
- An appendix of the report focuses on Internet pharmacies. The report raises concerns over funding and jurisdiction issues on both the state and federal levels. The report concludes that: (1) the only new laws that need to be enacted should require on-line pharmacies to make certain disclosures or obtain certification; and (2) other existing laws are sufficient since on-line pharmacies are subject to the same laws as physical pharmacies. 2 http://www.usdoj.gov/criminal/cybercrime/unlawful.htm
State Initiatives
- New Hampshire enacted legislation, signed by the governor on May 26, 2000, that requires mail-order pharmacies, including internet sites, to register with and receive a permit from the state pharmacy board. The law also establishes requirements pharmacies must meet to receive a permit to conduct business in the state.
- Legislatures in Indiana, Illinois and Virginia enacted laws in 1999 related to on-line pharmacies. The Illinois law amends the state pharmacy act by requiring the department to adopt regulations governing on-line pharmacies. Indiana enacted a law that requires an on-line pharmacy to comply with the licensure laws of the state the on-line pharmacy is domiciled. Virginia adopted a resolution requiring the Board of Medicine and the Board of Pharmacy to study the sale of prescription drugs via the Internet. Obtain the final report on-line at: http://www.dhp.state.va.us/BHP/internet_prescribing_study_report.htm.
- Attorneys General in Arizona, Kansas, Missouri, Illinois, Michigan, New Jersey and Pennsylvania are actively pursuing illegal on-line pharmacies doing business in their states. During the National Association of Attorneys General's Spring Meeting, the association adopted a policy that: (1) Supports federal legislation that would grant authority to State Attorneys General to obtain nationwide equitable relief in federal court to combat unfair and deceptive acts or practices occurring over the internet; and (2) Supports federal legislative efforts to ensure that state consumer protection laws are not preempted; and that states have the option to enforce both federal and state consumer protection laws in federal court.
- At least twelve states have taken action against physicians for prescribing violations (California, Colorado, Florida, Hawaii, Illinois, Michigan, Missouri, Nevada, Ohio, Washington, Wisconsin, and Wyoming).3
- At least nine states have adopted rules or statements that clarify standards for on-line prescription and distribution of medicine (Alabama, California, Florida, Maryland, Missouri, Nevada, North Carolina, Ohio, and Texas). 4
- In January, the Michigan Department of Consumer and Industry Services established an Internet Prescribing Task Force to review current rules and statutes regarding Internet prescribing, telemedicine and mail order pharmacies. The task force will submit findings by the end of this year. 5 http://www.cis.state.mi.us/media/press/00press/00jan/internet.htm
Private Sector Initiatives
- The National Association of Boards of Pharmacy has developed the Verified Internet Pharmacy Practice Sites (VIPPS) program that establishes certification requirements that show a pharmacy complies with the licensing and inspection requirements of their state and each state in which they dispense medications. Complying sites will display a seal indicating that it meets the established standards regarding patient privacy, authenticity of prescription orders, and quality assurance. 6
- The Federation of State Medical Boards Committee on Professional Conduct and Ethics is considering a policy that would make it unprofessional conduct for a physician to provide treatment recommendations, including prescribing medicine over the Internet, without taking an adequate medical history and doing a physical examination. 7
- The American Medical Association Board of Trustees issued a background report on Internet Prescribing in 1999 that states that, among other things, that the AMA vigorously opposes the use of the Internet as a tool to prescribe medications in the absence of safeguards. 8
Assembly on Federal Issues
- Briefing on President Clinton internet pharmacy proposal, the Internet Prescription Drug Sales Act of 2000,by Margaret M. Dotzel, Senior Policy Advisor, Office of Policy, Planning and Legislation, Office of the Commissioner, Food and Drug Administration. (May 5, 2000).
Publications
- AFI Health Committee: Issues in Brief - Regulation of On-line Pharmacies. (8/1/00)
- Health Policy Tracking Service: Issue Brief-On-Line Pharmacy. (7/3/00). HPTS Contact: Claire Hackney.
ENDNOTES:
1 Food and Drug Administration, FDA Launches "Cyber" Letters Against Potentially Illegal, Foreign-Based Online Drug Sites, February 2, 2000.
2 Department of Justice, The Challenge of Unlawful Conduct Involving the Use of the Internet, Appendix D, March 9, 2000.
3 Statement of the Federation of State Medical Boards, Presented by Bruce Levy, MD, JD, Executive Director Texas State Board of Medical Examiners; Hearing on E-Drugs: Who Regulates Internet Pharmacies? Before the Senate Committee on Health, Education, Labor and Pensions, March 21, 2000.
4 See note 1.
5 Office of Media Relations and Communications, Department of Consumer and Industry Services Press Release, CIS Forms Internet Prescribing Task Force January 14, 2000.
6 National Association of Boards of Pharmacy: Verified Internet Pharmacy Practice Sites (VIPPS) August 3, 1999. www.nabp.net/vipps/intro.asp
7 See note 1.
8 American Medical Association Report of the Board of Trustees: Internet Prescribing 35-A-99.
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