Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -88

Accepted - Volume 2

Comment Record
Commentor Mrs. Dolly Lundberg Date/Time 2002-05-31 17:52:33
Organization Mrs. Dolly Lundberg
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? I resent being told by you on the label, just what YOU FDA think is good or bad about the product. Manufacturers and distributors of dietary supplements are free under the first amendment speech rights to tell their story of the uses for the particular product. It is the consumer's responsibility to research the claims and make one's own decision as to the use or not of the product, regardless of the claims of the manufacturer. It is ludicrous of the FDA to usurp that right. It does a great disservice to the American Consumer!!!
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 I rarely use prescription drugs, I don't have a real interest to comment on this section, except to say that when I wish to know what you or the manufacturer may say, claim, are the benefits and the risks of use, I am capable of researching the matter. With the great information highway available to even the least educated in this great country, again, the responsibility resides with the consumer to make the decision whether to use a product based upon available information.
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? More and more consumers are educating themselves regarding claims made by and through manufacturers and regulatory agencies such as you and your NL&E Act. I think the world would be a better place with a little less regulation and more education.
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 really don't care what size disclaimers and claims might be posted upon products. In many cases the disclaimers are made just to protect the drug manufacturers, FDA and other agencies. If placed there, no matter the print size, if the consumer chooses to read them, they will, even if they have to get glasses or a magnifying glass to do so.
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 am not aware of which type of warnings other consumers follow or disregard. I have no suggestions as to how you may or may not make them more effective.
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? Don't hinder manufacturers and suppliers from educating the consumer as to the merits and empiricle uses of their products/supplements whether it be in advertising or on the labels. Again, it is my opinion that the consumer or buyer beware, and take the responsibility himself as to the claims made regarding any product. Life's experience proves the wisdom in applying this habit to most uses and purchases through the years.
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? Keep your hands and mouths and regulations off of our FREE speech rights in all matters. Thank you.
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? No the restrictive regulations do not advance the health concerns of the public. In many cases they hinder.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Do not stop claims of dietary supplements and other products. Let the consumer make his own choices based upon his own decision-making processes.

EC -88