Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -363

Accepted - Volume 6

Comment Record
Commentor Ms. Liesl Wright Date/Time 2002-09-08 02:40:11
Organization Ms. Liesl Wright
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? Your function as a government agency is to protect consumer health. Direct-to-consumer prescription drug ads are hardly educational, vague and even misleading. Patients see these adds and push doctors for medications they may not need. Doctors often go ahead and prescribe a medication despite ambivalance regarding the appropriateness of the drug for a given illness. It is certainly not healthy for people to take drugs they don't need. Patients should learn about drug options from their doctors. Public health is your first concern.
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? DTCs do indeed lead to over-prescription of drugs. In the case of under-diagnosed diseases the best option would be public service messages that describe the indications of a disease and urge people to seek medical attention without naming specific drugs for treatment. DTCs do not educate much and clearly induce people to request drugs they may not need, leading to over-prescription.
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? The FDA should present warnings on food items containing sugar, potentially harmful additives and hormones. I'm sure you're aware of the growing number of diabetics in this country. I wonder if that has anything to do with the amount of sugar in seemingly harmless packaged food products available. Everything from canned chili to yogurt has some form of sugar in it. The American public is largly oblivious to the dangers of sugar. I'm a teacher and the school system is jam-packing student breakfasts and lunches with sugar every single day. CHILDREN are sugar addicted and more and more of them are being diagnosed with diabetes. Imagine the difference the FDA could make toward this frightening public health issue if it simply tagged every sugar containing package with a sugar content warning.
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? I don't have research data but I think it is only common sense to recognize that presenting disclaimers in small print is really just a way of hiding important information from the public. Many people don't notice it. My Grandparents CAN'T SEE IT! I think I could make a case that this practice impedes their right to know. Hmmm...somebody could get their butts sued.
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? I disregard warnings I don't see. Make them BIG and LOUD.
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? Do corporations run this country or do officials elected by the people run this country? I'm kind of thinking it's the corporations these days. Get a handle on it FDA. Of coarse you have the authority and a responsibility to protect the public. Frankly, except for cigarettes and alchohol you're doing a lousy job. No, as a matter of fact, the warnings presented on alchohol containers are pretty tiny. Ever hear of fetal alchohol syndrome or drunk driving or livers? Those warnings should be huge.
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? If the FDA has not approved the use of the drug then speech on such use should absolutely NOT be allowed. I can't believe you're questioning that.
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 FDA's speech-related regulations should be more, not less, restrictive.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The First Amendment was created for the rights of individuals, not corporations. I realize that it has been altered from it's original intent but it should not have been. Our founding fathers are turning in their graves. Had they known what the ravages of greed would do to the fine country they worked so hard to build I'm sure they would have made some provisions to prevent it. Exert your authority FDA!

EC -363