Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -105

Accepted - Volume 2

Comment Record
Commentor Mr. Kelly Peck Date/Time 2002-06-02 23:04:50
Organization Mr. Kelly Peck
Category Health Professional

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? All drugs are poisons, and tear down the body. Dietary supplements are nutritive substances, and help build up the body. All drugs have side effects, short and longer term. All advertising and all labeling for drugs should contain these statements: ALL DRUGS ARE POISONS. ALL DRUGS HAVE SIDE EFFECTS. MANY TIMES, THE NEED FOR STIMULATION COMES FROM POOR NUTRITION. EAT BETTER AND TAKE VITAMINS.
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 was recently revealed, most psychiatric drugs are no more effective than sugar pills, in the remission of insanity. In other words, people get better all by themselves; the drugs are ineffective. Worse yet, these drugs are often dangerously addictive. All advertising and lableling should state: DRUGS ARE VERY OFTEN INEFFECTIVE, AND VERY OFTEN RISKY. YOU ARE ENCOURAGED TO 'HEAL THYSELF.' and DRUGS ARE VERY OFTEN UNNECESSARY FOR OPTIMAL TREATMENT.
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? Human bodies require many nutritive substances to build and rebuild. Conventional foods, not grown under laboratory conditions, do not always contain expected amounts of all such substances. Therefore, supplementation is often necessary. Dietary supplement labeling should include some indication of the intended use of the product.
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? On drug labeling, all type should be the same small typesize, similar to the labeling on prescription bottles.
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? As above: On drug labeling, all type should be the same small typesize, similar to the labeling on prescription bottles.
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? More stringent monitoring of testing.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Get rid of the % DV crap. No one understands it and it just hides the facts.

EC -105