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Q&A on the FDA Request for Comment on First Amendment and Commercial Speech Issues What is the FDA's Request for Comment? What should I say in my comments? How should I present my comments? What is the existing law with regard to commercial speech? Why shouldn't commercial speech have strong constitutional protections? Relevant FDA Notices and Related Material Relevant FDA Notices and Related Material Suggestions for Submitting Comments On corporate constitutional rights and commercial speech On Direct-to-Consumer pharmaceutical advertising Background Infromation Corporate Constitutional Rights and Commercial Speech Direct-to-Consumer Pharmaceutical Advertising |
The FDA and Commercial Speech Protection Sidney Wolfe, " Testimony before the Subcommittee on Consumer Affairs
Hearing, Senate Commerce Committee on Direct-to-Consumer (DTC) Advertising,"
July 24, 2001 Public Citizen's Health Research Group, "Comments on proposed Food and
Drug Administration survey entitled FDA: Attitudinal and Behavioral Effects
of Direct-to-Consumer Advertising of Prescription Drugs," September 29,
1998 Amy Allina and Cindy Pearson, "Pills, Prevention and Profits: The Case
of Tamoxifen," Multinational Monitor, September 1999 DTC advertising as
part of a corporate campaign to mis-promote a drug. Shankar Vedantam, "Drug Ads Hyping Anxiety Make Some Uneasy." Washington
Post, July 16, 2001 Kaiser Family Fund, "Trends in Direct-to-Consumer Advertising of Prescription
Drugs" American Associationof Retired Persons (AARP), A "Medication Information
Gap" Skyrocketing DTC ads found to have little consumer educational benefit. American College of Physicians- American Society of Internal Medicine,
"Direct to Consumer Advertising for Prescription Drugs," October 1998
Takes position that DTC ads, though harmful, are here to stay but strict
regulation is key. Clearly outlines jurisdiction of FDA in advertising,
as well as history of FDA regulation in advertising. Raises concerns about
interference in patient-doctor relationship. Proposes FDA pre-review of
ads before airing. Phyllis McGuire, "How direct-to-consumer advertising is putting the squeeze
on physicians," ACP-ASIM Observer, March 1999. Discusses changed doctor
patient relationship as a result of DTC. Barbara Mintzes, et. al. "Influence of direct to consumer pharmaceutical
advertising and patients' requests on prescribing decisions: two site
cross sectional survey," British Medical Journal, February 2, 2002 Analysis
based on physician and patient surveys finds patients' requests for medicines
are a powerful driver of prescribing decisions. In most cases physicians
prescribed requested medicines but were often ambivalent about the choice
of treatment. If physicians prescribe requested drugs despite personal
reservations, sales may increase but appropriateness of prescribing may
suffer. Melody Petersen, "Increased Spending on Drugs is Linked to More Advertising,"
New York Times, November 21, 2001. Title explains story, based on National
Institute for Health Care Management study Judy Norsigian, "Feminists Challenge Unethical Marketing by Prescription
Drug Companies," Boston Women's Health Book Collective, 2001 The harms
of DTC advertising targeted to women. Cindy Pearson, "Direct-to-Consumer Promotion of Prescription Drugs,"
National Women's Health Network, October 1995 Strong opposition to DTC
advertising. Health Action Intenational, "Providing Prescription Medicine Information
to Consumers: Is there a role for direct-to-consumer advertising?" 2002
European analysts consider proposals to adopt U.S.-style DTC rules in
Europe, concluding that such an approach would undermine healthcare systems.
A comprehensive critique Charles Medawar, "Because You're Worth It: Drug Companies Want to Expand
Sales by Marketing their Products Directly to the Public," Health Matters,
Winter 2000/2001 |
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