Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -304

Accepted - Volume 4

Comment Record
Commentor Mr. praveen gonugunta Date/Time 2002-09-04 19:30:27
Organization inktomi corporation
Category Individual

Comments for FDA General
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? the negative effects of industry promoting certain drugs - A very clear example that I see in my day to day life is that of drugs like lipitor that _claim_, probably backed by some sort of scientific study to reduce cholesterol level in blood. This kind of advertising, only encourages the already highly obese population of the united states to get more obese. They dont have to worry about high cholesterol anymore because there are drugs now to cure that condition. They can eat as much fat as they would like to and still can reduce the risk of heart disease by spending enough money.
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? A fairly large portion of the consumers do believe completely in all the claims made on products. Especially when they're printed in bright colors to catch the eye. The disclaimers if any, are often found in small, hard to read print somewhere under the box. I have a graduate degree and consider myself fairly knowledgeable person. but I myself donot find any reason not to believe claims made on products, because its my conviction that the appropriate regulatory agencies(FDA for example) would have already tested these products and verified their claims. Now, if that isnt the case, then I would have a very tough time buying products because I donot have the means or the time to verify the claims made by each product. I therefore, believe that dietary supplements should fall under the purview of the FDA approval process and claims made on these products need to be verified.
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? yes I very much believe this is required.

EC -304