Q&A on the FDA Request for Comment on First Amendment and Commercial Speech Issues

What is the FDA's Request for Comment?

When are comments due?

How do I submit comments?

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

On Tobacco 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
Failure of FDA to enforce its own DTC regulations, plus specific problems with DTC ads.

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
Contains a review of medical literature on DTC advertising

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
The story behind the marketing of Paxil, the drug for hyper-hyped "social anxiety disorder."

Kaiser Family Fund, "Trends in Direct-to-Consumer Advertising of Prescription Drugs"
Report examines the increases in spending by pharmaceutical manufacturers to advertise prescription drugs directly to consumers. The report's findings also address how this spending compares to advertising in other industries, the drugs most heavily advertised to consumers, and the increasing public awareness of such advertising.

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
A UK perspective on DTC ads.

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