Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -390

Accepted - Volume 6

Comment Record
Commentor Ms. Denise Lankau Date/Time 2002-09-10 21:34:31
Organization Ms. Denise Lankau
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 drugs is something that needs to be addressed to the proper audience. My 2 year old was watching Sesame Street one day when a commercial came on for Phizer. The ad was teaching children that Z is for Zithromax. This is inappropriate. Drugs are advertised all day to all audiences. Advertising drugs to the wrong audiences is harmful. Since it is not possible to know who will see what ads at any given time on tv or hear them on radio, advertising should be limited to the appropriate written forum. Advertising shouldn't be limited to medical journals, but should not be allowed in publications geared toward minors.
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? Prescription drugs were over-prescribed before advertising. Advertising only makes it worse. The public doesn't need to be brainwashed by drug ads. Many people go to the doctor and expect a prescription even if they don't really need it. What difference does it make it someone is more compliant with a drug regimes if they don't need the drug? The pharmaceutical industry can not be treated like every other industry.
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? As a consumer, I do not look at the claims of conventional foods and dietary supplements differently. Manufacturers should just tell the truth without twisting it. They should not be making any claims. Low Calorie, for example, means what? Lower than some other brand? Lower than a previous recipe? There are too many interpretations. Just the facts...200 calories per 4 oz. serving. There is too much maniputlation in the gray areas. I should buy a product because of what it is, not what the manufacturer would like me to believe it could be.
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 larger and more prominent so we can see the truth more clearly than the lies.
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 the largest print on the package contain the warning and don't allow advertising that attempts to hide the dangers. The most dangerous products should not be advertised to the general public, like cigarettes and drugs.
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? You don't get to tell the truth on the label and lie in the advertising. There should be no difference in the claims made in the advertising and those on the labels. Just the truth, the whole truth and nothing but the truth. The first amendment applies to people, not corporations.
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? The FDA should have to approve a use before there is any speech about off-label uses except within the medical research community. The public will latch on to what they think may be a silver bullet only to find out later that it is deadly. If we allow off-label marketing, what is the purpose of the FDA?
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? Right now, it looks more like the FDA is advancing the concerns of the drug manufaturers, not the public. Advertising to the general public causes the public to want more drugs that we don't need and can't afford to pay for.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should be protecting the public. The drug companies are very strong and wealthy. The public doesn't stand a chance against their efforts to promote their products at all costs if they are not monitored tightly. Medical decisions should be made between a doctor and a patient, not between an individiual and the television set. The FDA should help make sure that medical decisions remain medical decisions, not consumer decisions.

EC -390