Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -194

Accepted - Volume 4

Comment Record
Commentor Ms. Martha Goodwin Date/Time 2002-07-25 20:03:45
Organization Ms. Martha Goodwin
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? It is unconstitutional to pass such a law. If ANYONE has read and understands the constitution of the United States of America it is perfectly clear that taking away such rights is against our constitution. Protect not only the people but the constitution and what is stands for. I am tired of laws that are being made out of the ignorance of congress and legislatures rather than the support of the constitution. Educate yourself lawmakers. Read your constitution. Also, The FDA was originally organized to protect and educate the less educated People are more educated and take responsibility for their education. Our citizens can not be fooled by the control that the FDA tries to impose upon them.
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? Absolutely. I work in a state medical institution that is testing supplements to determine which ones are medically significant.
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? Based on clinical studies.....that's the claim that the FDA makes. Make the supplement companies do the same.
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 the same as cigarettes, etc.
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? Yes. Similar to cigarettes. For instance, Use as directed. Do not use more than prescribed.
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? Labels should be documented with clinical facts only.
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? No. If anything, the FDA can demand that only information from clinical studies be stated. The FDA needs to be an advocate for the public not BAN anything from the public . No allowing the information that is fact not be be published for the public to read is saying that the FDA is fearful of education getting to the citizens. Why not let the citizen RECEIVE the education. Something is not right with the FDA for wanting to Ban the speech. As long as the claims can be proven. Let is be known.
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. As always, the FDA is looking out for the almighty dollar and not for the people.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. They need to get off of the deceit roller coaster and if they want to do the job they were organized to do....Educate the people, dont keep it from them.

EC -194