Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -442

Accepted - Volume 6

Comment Record
Commentor Ms. Ann Fonfa Date/Time 2002-10-18 11:04:51
Organization The Annie Appleseed Project
Category Consumer Group

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? In the United States, we are very used to advertising of products. Many people use advertising to help them choose which brand they will buy. When it comes to drugs, therefore, it is almost a given that consumers will believe that they are receiving appropriate information. That would mean all the information and in a useful and understandable format. 'Learned intermediaries may be even more likely to accept the claims(advertisements) since they are conditioned to through their years of training and intermingling with pharamceutical sales reps (personable, likeable folks who spend liberally). Advertising in general tends to work on the theory of the 'big lie'. That is, many ads directly attack the weakest argument and speak against it directly. Thus a snack ad will argue for the value of its food. An artifical product will argue for its taste. And so on.
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? As advocates for people with cancer, we have noted in the past that drug advertising can indeed be false and misleading. Quoting statistics relating to relative risk on the risk side, and absolute risk on the benefit side, is enough to skew the entire advertisement.
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? Right now, consumers are tending to believe dietary supplements are all safe. It is almost like a consumer groundswell against drugs and their dangers. Yet we know that dietary supplements need to be accurate in their labeling, the manufacturers must practice GMP. There are hundreds of studies in support of many different dietary supplements but these are not allowed to be used in support. Many substances in our food are not safety-tested. If they have been used for a long time (grandfathered) then no one is checking them. We request that FDA look over food additives of the past. After all, the United States has a huge and growing incidence of cancer that can hardly be explained.
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 LARGE. People can easily miss them when they are small. There are studies on how to place graphics/text to best notice them.
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? They need to be clear and in basic terminology, aka lingo.
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? Again, it is important that relative risk and absolute risk not be used interchangeable as they are DIFFERENT.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? It seems clear that the genie is out of the bottle. Off label use is growing constantly. It is our belief that the entire system for drug approval could use an overhaul. When a drug has been approved at a too high dose, the only way to correct this is for the sponsor to spend more of their own money. Not going to happen. FDA should make sure that any further requests examine the dosage more carefully. We need a system for changing the product's dose when we discover the downsides in the real world. Phase IV is not used enough.
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? Advertising by its very nature is designed to accentuate the positive. It is a trickster business and it needs constant oversite!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? This question requires us to know all about the FDA practices. We do not. As a consumer organization, we urge FDA to protect the consumer first. That is and should remain FDA mandate.




EC -442