Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -127

Accepted - Volume 2

Comment Record
Commentor Mr. Edward Robles Date/Time 2002-06-17 17:18:56
Organization Mr. Edward Robles
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? Whoa! First, you need to STOP defining FOODS as DRUGS!
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? TV advertisements for Drugs cause ME to write down the name of the offender on a long list of Things not to purchase! My feeling is that if it is necessary to advertise a Remedy, it is probably either useless, harmful, or both.
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? No, No, and NO!!!!! (See comment on #1) JUST BUTT OUT! If I want to eat my way to Health, I should be allowed to - and if I'm damn fool enough to think bananas cure cancer, I should be allowed so to think. The FDA has a long history of overreacting, and it should stop! Especially, it should stop making guns-drawn raids on perfectly innocent Health Food Stores and Doctors' Offices!
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? The only requirement I would have for Claims is a literature reference. The disclaimer should be conspicuous by its absence. Just because the FDA has not evaluated a statement does not mean that it is false. I WISH you'd start Examining the so-called Ethical Drugs with the same član you use for vitamins, minerals, Herbs, and amino acids. AT LEAST, THESE ITEMS DON'T KILL OR CRIPPLE ANYONE, a statement which is put in the shade by the quarter million annual Iatrogenic and Nosocomial Deaths, and God alone knows how many crippling illnesses!
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? What warnings? The ones that SHOULD be on Aspirin, and aren't? Or the ones that warn you that Sasafras can cause cancer and require that iso-Safrole be removed from a beverage before sale that thousands of our Ancestors drank without harm? Frankly, you tend to throw the baby out with the bath entirely too often, and holler Wolf when it's a puppy-dog. Honestly, in your zeal to Protect everyone from everything except Prescription Drugs, you have made yourselves totally unbelievable. For only one example of your NEGLIGENCE, WHERE ARE THE WARNINGS ON Trans-Fats? And on Canola Oil? And on Aspartame? HMMMM?
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? Oh, My GOD! Are you on that kick again???? If you would spend the time, effort, and energy on, for instance, the various -statins, etc., that you waste on supplements, you might actually do some real good. As it is, you are wasting your time. When people try out a supplement and it doesn't help their condition, whatever it may be, they stop using it; but when people are given a prescription for something and it does no good, or even harms them, their physician is likely to tell them to keep on using it, or may even prescribe something more hazardous! (And this with the blessing of the FDA, thanks to Estes Kefauver, who did not realize what a monster he was creating!)
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? That requirement should simply be either repealed, or at least ignored. If something intended to treat ingrown toenails shrinks carbuncles, who cares? AS LONG AS IT IS EFFECTIVE FOR THE OFF-LABEL USE, AND DOES NO HARM TO THE PATIENT, THE FDA SHOULD - AGAIN - BUTT OUT!!!!!!!!!!!!!!!
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. JUST BUTT OUT.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yeah. Stop persecuting Health Food Stores and go after the REAL Criminals - the drug manufacturers and Physicians who prescribe dangerous drugs wrongly!

EC -127