Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -141

Accepted - Volume 2

Comment Record
Commentor Ms. Selma Thompson Date/Time 2002-06-29 23:00:06
Organization Ms. Selma Thompson
Category Individual

Comments for FDA General
Questions
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? 1. DIETARY SUPPLEMENTS ARE NOT DRUGS AND SHOULD NOT BE MONITORED BY THE FDA!!!!!!!! 2. DIETARY SUPPLEMENTS ARE NOT DRUGS AND SHOULD NOT BE MONITORED BY THE FDA!!!!!!!! 3. DIETARY SUPPLEMENTS ARE NOT DRUGS AND SHOULD NOT BE MONITORED BY THE FDA!!!!!!!!
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 FDA NEEDS TO STICK TO THEIR JOB OF REGULATING DRUGS. IF THEY DID A BETTER JOB OF--1. MAKING SURE THERE IS ADEQUATE DRUG TESTING, AND 2. FINDING OUT ALL THE SIDE EFFECTS OF ANY DRUG--BEFORE ANY DRUG IS EVER RELEASED, THEN DRUGS WOULD NOT BE KILLING SO MANY PEOPLE----LEGALLY!!!!!!
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? I AM AN INFORMED,INTELLIGENT AMERICAN, WITH FREEDOMS AND RIGHTS IN PLACE THROUGH MY CONSTITUTION. I DO NOT WANT OR NEED THE FDA, OR ANY OTHER REGULATORY AGENCY, TREATING ME LIKE AN IGNORANT CHILD. I DO NOT WANT THE FDA MAKING MY DECISIONS FOR ME, OR TRYING TO LIMIT MY FREEDOM OF SPEECH!!
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? ONLY WHEN THE FDA PUTS DISCLAIMERS ON DRUG BOTTLES CITING HOW MANY PEOPLE HAVE DIED, OR BEEN ADVERSELY AFFECTED BY THAT DRUG, SHOULD THEY EVEN THINK ABOUT HAVING ANY INPUT ON NON-DRUG SUBSTANCES!!!
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? SEE #4 ABOVE!!!!!!!!!!!
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? THE GOVERNMENT HAS NO BUSINESS INTERFERRING WITH NON-DRUG SUBSTANCES--ESPECIALLY SINCE THEY CANNOT EVEN PROPERLY REGULATE DRUGS!!!!!!!!!!!!!!!
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? READ MY LIPS : STOP INTERFERRING WITH MY FIRST AMENDMENT RIGHTS!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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! NO! THIS IS NOT THE FDA'S BUSINESS! STOP TREADING ON MY FIRST AMENDMENT RIGHTS!!!!!!!!!!!!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? THE FOLLOWING IS A STATEMENT FROM THE HEALTH SCIENCES INSTITUTE, WITH WHICH I AM IN TOTAL AGREEMENT : WE CONSUMERS HAVE THE RESPONSIBILITY TO BE DILIGENT ABOUT EDUCATING OURSELVES WHEN WE CHOOSE ANY PHARMACEUTICAL OR DIETARY SUPPLEMENT.... THE FDA HAS LONG OVERSTEPPED ITS REGULATORY BOUNDS BY ENFORCING THESE MISGUIDED DISCLAIMERS. IF ANYONE IS CHARGED WITH PROTECTING CONSUMERS FROM FALSE CLAIMS, IT'S THE FEDERAL TRADE COMMISSION. THE FDA'S MANDATE IS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF PHARMACEUTICALS, FOODS, COSMETICS, ETC. THE FDA DOES NOT PROTECT THE HEALTH OF THE TAXPAYERS WHEN IT TAKES THE UNNECESSARY STEP OF REQUIRING LABELS TO CARRY DISCLAIMERS--BUT IT DOES PROTECT THE GIANT DRUG COMPANIES WHO STAND TO LOSE MILLIONS IF MORE AND MORE CONSUMERS CHOOSE TO IMPROVE THEIR HEALTH WITH SUPPLEMENTS AND REDUCE THEIR NEED FOR HIGH PRICED PHARMACEUTICALS.... THE FDA NEEDS TO GIVE UP THIS SELF-APPOINTED REGULATORY POWER THEY SEIZED MANY YEARS AGO!! STOP INFRINGING ON MY FIRST AMENDMENT RIGHTS!!!!




EC -141