Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -125

Accepted - Volume 2

Comment Record
Commentor Mr. scott grossman Date/Time 2002-06-17 16:38:12
Organization Mr. scott grossman
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? Dietary supplements should be treated as food is treated in terms of labeling.
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? Your questions are too long and complex. Please break them down into individual questions. Aside from the fact that I believe the FDA and pharmaceutical companies are in league with one another and against the natural supplement community, yes pharmaceutical advertising leads to increased prescribing and increased medical issues as a result of side effects. When one person dies from a natural supplement it engenders as much attention from you and the media as a prescription drug with 100's of deaths.
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? Treat foods and supplements the same.
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? Claims on foods and supplements should be clear and disclaimers should be separate but equally clear and equally sized. Drugs are in a different category because they are chemicals and combinations not found in nature so side effects should be even more clearly set out. Any food or supplement that includes man-made ingredients or effects(as in herbacides/pessticides/altering of natural ingredients) should be clearly laid out.
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? Chemical fertilizers and pesticides/herbicides do it well. The label on the front lays out what it's for and the label on the back gives warnings and details(if need be these are fold-out types to give ample space for all the necessary info.
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? Truth in advertising is almost a joke whether on TV or in print but certainly in the media. Again, the producers and the media and the regulatory agencies are in bed together so bullshit claims like America's choice or the best on the market or most other such statements are never held up to the light and no one is protecting the consumer from irresponsible claims for which no one is held accountable.
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? If the FDA were truly independent and fair then I'd give it even more power to regulate all claims. And by fair I suggest that any product that is man-made or man altered should be treated differently than their counterparts.
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? See above
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, as long as the costs of getting your approval are so astronomic it eliminates much of what may be of benefit to the public. Again, for man-made substances, in order to protect the public, the requirements should be very strict, no matter what the cost. However, natural substances should be given a different criteria and standards. I'm not suggesting that my recommendations are easy e.g. just cause a cow hasn't had any chemicals used in the food etc doesn't mean she hasn't been drinking out of a polluted water source, but your job is to be fair and to keep the public's safety in mind. Drug companies with huge resources who contribute to the independent testing resources bottom line are not fair or ethical. Similarly, when their wealth is utilized to influence you it works against the spirit and letter of your charter.

EC -125