Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -276

Accepted - Volume 4

Comment Record
Commentor Mr. David Jonas Date/Time 2002-07-29 22:25:47
Organization Mr. David Jonas
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? Statistically, drugs are far more dangerous than supplements. Virtually no one dies from taking supplements (if any). Hundreds die daily because of prescription drugs. Of course there should be a difference in regulating information and advertising. Furthermore, neither drugs nor supplements cure anything but either may be useful so that the body can heal or cure itself.
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? Drugs are greatly over-advertised and even though the specific language does not do so, the presentation and repitition imply that they are a panacea. Eighty percent of communication is non-verbal (right brain) so a purple pill is perceived on the same plane with a purple dinosaur causing a gullible public to ask their doctor if it's 'right' for them -- never mind the potential life-threatening side effects. Madison Avenue now has drugs right up there with Dairy Queen while every news blip about herbs or supplements make them sound like a loaded shotgun. Drug companies should do their advertising and educating to the professionals who dispense these poisons and not the unsuspecting, uneducated, incapable public. Doctors are most certainly under undue pressure to give patients what they want -- even if it kills them. The public is highly over-medicated. Who knows what really goes on in the mind of the lopsided FDA?
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? Ninety percent of the public doesn't read labels. Regulating contents would be far more important than tiny print on a label. Actual ingredients should be listed with common usages for supplements. Foods are selected primarily for taste rather than nutrition. Additives and preservatives should be listed. Foods and food supplements should actually contain what the labels say. This alone would eliminate much of the problem. People rarely take drugs, supplements or food in the proper amounts.
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 are a joke. Quality and content are far more important. Media advertising is in much more need of the regulation. People buy impulsively and the unfettered advertising makes a far greater impact than anything written on a bottle, regardless of size. We need to look for the causes of problems instead of stupidly focusing only on the symptoms.
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? People who read labels will most likely heed warnings however they are written. People who don't read labels won't be affected no matter how you warn them.
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? Advertising is far more powerful but neither advertising nor labeling should be restricted from REASONABLE claims. Find the shysters and punish them.
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? Virtually none. The FDA doesn't have the capacity nor even the expertise to regulate speech, especially off label. The public isn't protected at all from neferious vendors or products such as FenPhen. Look for the bad guys and the irresponsible and punish them.
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? Give the public some credit for being able to make up their own mind and do more educating on issues that need exposure. The FDA is very lopsided when it comes to the difference in allopathic and alternative medicine. 80% of the world never sees an aspirin or a doctor.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should truly focus on protecting the public from the real dangers instead of trying to regulate free speech. Go after the guys who yell fire in a crowded theater, the irresponsible drug companies and supplement companies and not yet bogged down in bureaucratic 'nit-picking' that most of the time only hinders the good guys. Surely there's some honesty and integrity left on both sides.

EC -276