Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -398

Accepted - Volume 6

Comment Record
Commentor Mr. Tom McCarty Date/Time 2002-09-11 09:49:04
Organization Mr. Tom McCarty
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? Doctors are likely to prescribe drugs seen on TV by their patients even though they might not think them the most appropriate, because patients demand them and the Doctor does not want to lose their patient. These adds encourage consumers to demand needlessly expensive drugs that drive the cost of healthcare up, because the drugs advertised are always the higher cost ones. The language used in these adds simplifies drug prescription and leads consumers to think that they are able to know what drugs are best for them, when they are in no way qualified to make these desisions. Sidney Wolfe Testimony before the Subcommittee on Consumer Affairs Hearing, Senate Commerce Committee on Direct-to Consumer 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 Sept. 29, 1998 Amy Allina and Cindy Pearson, Pills Prevention and Profits: The Case of Tamoxifen, Multinational Monitor, Sept. 1999 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 Association of Retired Persons [AARP] A Medication Information Gap 04 advertising.html Phyllis McGuire How direct-to-consumer adverising is putting the squeeze on physicians ACP-ASIM Observer, March 1999 Melody Petersen, Increased Spending on Drugs is Linked to More Advertising New York Times, November 21, 2001 Cindy Pearson, Direct-to-Consumer Promotion of Perscription Drugs, National Women's Health Network, October 1995
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Disclaimers should be required to be in at least the same size print and should be emphasized, in a bright color for example, because they could change someone's mind on wether they decide to use that drug. Just common sense!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Given the widespread abuses of DTC advertising, drug companies should be required to run corrective adds after receiving FDA warning letters so consumers can be fully informed of the dangers associated with these findings. Because of the numerous initiatives to give the FDA regulatory powers over tobacco and this will probably eventually happen, and it is known that tobacco advertising leads to increased smoking by children, this should also be considered in the FDA's stance on commercial speech issues. Tobacco companies well know the importance of advertising to hook new smokers to their deadly product so in the pulic interest this should also be a consideration.

EC -398