Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -417

Accepted - Volume 6

Comment Record
Commentor Ms. Cheryl A. Davis Date/Time 2002-09-13 12:05:59
Organization Ms. Cheryl A. Davis
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? Speech about both drugs and dietary supplements should be regulated. The laws regarding free speech belong to individual citizens, not to corporations. Corporate speech inherently risks misleading the public and is, in fact, devoted to convincing non-experts of the safety, efficacy, and superior nature of drug and food suplement products. Freedom of speech is intended especially to protect the speech and opinions of individuals with regard to political and religious beliefs. To grant free speech rights to corporations essentially protects a corporation's ability to shill for a product, with no regard to whether the promised benefits are even real. The only way to halt corporate advertising would then be to charge it with outright fraud, which can be expensive and time-consuming --well beyond the ability of individuals, qualified health care providers, and the FDA to regulate, except on a case-by-case basis, which would exhaust the budget, confuse and possib ly injure the public, and tie up the FDA in litigation for the indefinite future.
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? Possible positive effects of industry promotion of prescription drugs is that a person who needs care may learn of available treatment for his problem. Negative effects far outweigh this, often leading to an uninformed patient insisting on unnecessary, costly, or dangerous treatment for a problem which is minor, easily treatable with safer, cheaper drugs, or would go away by itself. In addition, such advertising can promote excessive use of antibiotics, which the FDA should have an interest in preventing. Drug advertisements, especially on television, have already been proven to confuse the public; Nexium, for example, has been promoted by showing people marching and rising through surreal, rocky landscapes to the tune of triumphal music, virtually drawing attention away from the many caveats connected with the drug or, indeed, of what is actually being offered. The result is that not only are patients with severe heartburn with esophageal damage attracted to Nexium, but even those with mild heartburn who may need little more than OTC Gas-X or Tums, which represents a costly misuse of a drug with many side-effects. Selling drugs in this way probably results in excessive doctor visits and unnecessary use of medication. In fact, the costs of advertising drives up cost of drugs to the point where, if they are needed, the drugs are apt to become too expensive for those patients who need them to afford them. And the patients have no idea when they take these heavily advertised drugs, that older drugs may be safer and cheaper. Today's drug-advertising environment essentially make drugs trendy in a way that has no relation whatever to their efficacy.
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 certainly be larger and appear right on the container, where consumers are more likely to see them. Since elderly people take more drugs and often have vision problems, elderly people especially should have their attention drawn to disclaimers. Research shows that ordinary people tend to throw away inserts without even reading them. Small-print disclaimers are apt only to provide legal protection to the corporations, instead of helping consumers.
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? The only warnings that consumers may pay attention to are those coming from their own doctors. There is already ample reason to believe that consumers are greatly confused by pharmaceutical advertising. The main message they take away from drug advertisements is the idea that This drug is the next big thing. I see no reason for the FDA even to allow so much direct-to-consumer advertising. Few consumers, for example, would even ask for Celebrex if they knew that it cost more than aspirin and ibuprofen, but was no more effective.
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? There is ample reason to believe that televised advertisements speak louder to the human unconscious than claims on labels. Drug-consumption is a serious business and should not be allowed to imply promises that are visually enhanced in a way that mixes fantasy with basic facts and warnings. Labels are virtually devoid of fantasy-promotion today, unlike television and other media, and they should be. The First Amendment does not exist to promote dreams.
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? The regulations are inadequate if they allow the unfettered advertising of drugs. Unrestricted self-promotion is not one of the rights of the First amendment. Restrictions on commercial speech, especially with regard to drugs and food supplements alike, are essential to protect the public health. Only ideology drives the effort to reduce restrictions on speech; it should be ignored. The framers of the Constitution, I am sure, never intended the First Amendment to protect the right to hock dubious drugs and devices.

EC -417