Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -211

Accepted - Volume 4

Comment Record
Commentor Mr. Richard Brooks Date/Time 2002-07-26 10:25:48
Organization Mannatech Inc.
Category Other

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? Pharmacuitical companies mislead about their drugs that are deadly. If someone is talking about natural products, they're the most limited out there. The constitution was put in place to limit government, yet the FDA's goal is to limit people.
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? Mis/over prescribed pharmecuiticals are the #4 killer in the US today. In my line of work, we call that a clue! One question at a time please.
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? YES! To put it simply.
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? No, in my opinion, the general public has a responsability to educate themselves. There should be no need for disclaimers on natural products.
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 know one! This DRUG may kill you at some point! I think that would catch any consumers attention.
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? NO!!! The First ammendment LIMITS Government!
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? The last time I checked, I lived in the United States of America. I served my country in the military and still do today outside of the military. I never recall any government agency having ANY ability to regulate speech over the general public. Read what it is that you may do first, then ask the question.
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? If a person cannot be educated in an objective way, ofcourse that is limiting. The FDA could do what it is intended to do and simply be a quality control guide.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA has NO governing authority over any portion of the constitution, let alone the first ammendment. You can start by destroying the policies that you have that pretend to give you any authority over the US constitution in the first place.

EC -211