Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -375

Accepted - Volume 6

Comment Record
Commentor Mr. Jonathan Bines Date/Time 2002-09-09 17:41:15
Organization Mr. Jonathan Bines
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? As a consumer, I am extremely concerned about the FDA's current laxity in permitting direct-to-consumer advertising by the pharmaceutical industry, as distinct from advertising directed at learned intermediaries. The intent of advertising speech is to increase sales of the product advertised. It is NOT to educate. If education serves the purpose of increasing product sales, that may be a component of an adverising pitch, but advertisements cannot be counted on to provide information sufficient for a consumer to make an educated choice. To the contrary, their explicit goal is to move the consumer to choose the advertised product, and advertisers routinely make false, misleading, or incomplete claims for their products as part of their speech, which could certainly sway an uneducated consumer towards the advertised product and away from potentially superior therapeutic alternatives. For this reason, direct-to-consumer advertising must be considered a separate issue from advritising directed at learned intermediaries, and the standards must be far higher. Indeed, as a consumer who has been subjected to a barrage of advertising by the pharmaceutical industry over the past two years, I am extremely concerned that such advertisements puts consumers at risk of making healthcare decisions that could affect not only their wallets but their health and their lives. As there is no competing public good to such advertising, but only the private gain of the corporation, represented by increased sales, I strongly urge the FDA to ban or restrict to the extent permitted by law such direct-to-consumer advertising.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? The FDA should ban direct-to-consumer advertising of prescription drugs, due to the likelihood that drug companies will abuse such speech rights by making false or misleading claims for their products in order to increase sales, with serious health consequences. (See above) As a consumer, I rely on the FDA to protect me from the health risks related to false or misleading speech by drug companies. Unfortunately, product warnings muttered at high-speed at the end of television spots, or compacted into tiny windows in print advertisements, bear little weight when juxtaposed with advertisers' vivid images of happy, healthy consumers and compelling pitches for their products. In my experience, echoed by many I have spoken with, the required warnings do little or nothing to provide adequate understanding of the potential risks associated with the use of drugs. That requires the advice of a trained health-care professional, nothing less. I therefore strongly urge a ban on direct-to-consumer ads, or such restrictions as are permitted by law.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? Whatever the semantic distinction, labels are a form of advertising and should be subjected to the same restrictions as any other form of advertising. As a consumer, whether I read a health-related claim from a pharmaceutical company on the label of its product, or in a direct-to-consumer advertisement, the effect is the same. If anything, the label would be more influential, since I would presumably be seeing it in a store, in my search for a remedy.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? To the contrary, the FDA should increase restrictions on commercial speech relating to prescription drugs. Given corporations' obligation to shareholders to seek profit maximization, their communications can be assumed to promote this goal, and not the education of the consumer. Since its intent is to increase sales, rather than to educate, commercial speech by drug companies is extremely likely to have immediate adverse health effects, either by misleading consumers, failing to educate them about alternatives, or promoting drugs for treatments for which their effectiveness has not been proven. Rather than seek alternative approaches with fewer restrictions, the FDA should act to rein in the proliferation of direct to consumer advertising as an immediate public health hazard.

EC -375