Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -401

Accepted - Volume 6

Comment Record
Commentor Mr. Michael Freedman-Schnapp Date/Time 2002-09-11 11:35:31
Organization Mr. Michael Freedman-Schnapp
Category Individual

Comments for FDA General
Questions
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? Speech about any product should be regulated so that it is neither false nor misleading. The higher the level of technical expertise required to judge claims about a product, the more tightly regulated the speech should be. For example, a paper towel may be advertised as “the strongest, longest-lasting picker-upper” or some similar trite trope. This is a claim that any layperson may judge for themselves through experimentation with the product, as they likely have experience in using a paper towel. Claiming that a product “stops heartburn fast” would require an intermediate level of scrutiny, in that it is making a specific claim about a medical condition. If the product were actually a pain-killer, it might indeed be able to stop the sensation of heartburn, but not the digestive problems that underlie the sensation of heartburn. Were this claim regulated by non-commercial speech laws, it would probably pass muster, but were the FDA to scrutinize it closer, it would be able to raise hackles on the fact that the claim is misleading on the grounds that product does not actually treat heartburn. The highest level of scrutiny should be paid towards commercial speech on prescription drugs. Since the FDA requires multiple clinical trials conducted by medical experts to approve a drug for human use, there is clearly a substantive knowledge and skills barrier to understanding claims about a particular drug. A non-physician could likely not understand the nuances of risks associated with taking particular medicines (I certainly have a tough time with it). Therefore, speech on prescription drugs must be as tightly regulated as possible to guard against misleading or false statements made in promotions of that product.
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? I am not a medical expert and could not comment on the over-prescription aspect of this question, but I can make a common sense statement on this matter. This advertising is deeply disturbing, as it harps on people’s fears for the sake of profit.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? Yes, people typically think of dietary supplements in the category of substances that can “fix” or “improve” them in certain ways-- make them thinner, less susceptible to disease, or retain facts better. While assorted claims of this sort are certainly made about foods, these “ameliorating” effects are the reason people take the dietary supplements, not because of their taste or because people require them for nourishment.
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 must be in the same or larger size type as claims, and must be placed either along side the claims or in the same sentence or paragraph as the claims. Common sense dictates this-- think of the legitimizing effect on an advertisement when a company places an ad that looks like a news article in a newspaper.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Make warnings in plain, simple language with standardized icons (like those that used to adorn prescription medicine bottles at the Giant supermarket 10 years ago).




EC -401