Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -29

Accepted - Volume 1

Comment Record
Commentor Mr. Hank h Date/Time 2002-05-28 22:29:46
Organization Mr. Hank h
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? What is the documented track record of deaths of prescription drugs and nutritional supplements? The FDA track record is not good... the FDA favorite leaning has been toward drugs and not the peoples choice alternative choices
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? Look at the budgets of the drug industry vs. their research budgets during the past five years. The misleading ads on TV are horrendous and lead many people down the wrong path, not understanding that they have dangers that are real... the docs are almost forced by the patient to prescribe as per the ads unrealistic portrayal of the success of the actors in the ad...
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? Is there a real threat to the consumer regarding these foods? The amounts of the ‘claim’ ingredients from my view are that they are very small that the 'medicine' value is very small. The ignorant buyer is probably not buying 'supplements' anyway... a reasonably informed consumer knows that the ads on foods are a joke...
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? As long as they are uniform on all packaging... what’s wrong with the standard one that the 'FDA has not approved...' products that work get referral audiences that are real... the 'worthless one' fade away quite quickly...
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 drug ads give such a profound illusion that 'it' is the solution without giving the facts about 1. Side effect & 2. The probability of success. When we tell the body to 'do' something - it (the body) decides to defend itself and those are 'side effects' etc... Sometimes quick and sometimes slow... Nutrition when it to poor it usually is just a waste of money... the record shows that it is rarely dangerous...
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? Understanding the legal purpose of the FDA in the first place - what right does it have the stop free speech and not honor the laws on the books now?
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? label and ads warnings that the FDA has not endorsed should be the extent... the FTC etc has the ability to question the validity now...
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? answer #7

EC -29