Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -28

Accepted - Volume 1

Comment Record
Commentor Mr. Jon Barron Date/Time 2002-05-28 22:23:22
Organization Mr. Jon Barron
Category Academic

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? Absolutely. Most drugs have significant side effects even at normal dosages. The worst that can be said about most supplements is that they “over promise.” Even those that may be “harmful” are only harmful at significantly higher than recommended dosages. 106,000 people die each year from properly prescribed drugs. The number of people who die from misused supplements is probably under 50 each year.
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? Advertising for prescription drugs leads to a significant increase in self-diagnosis and the concomitant increase in the use of drugs. It also significantly underplays and distorts the negative side effects associated with those drugs.
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? Keeping in mind the sorry track record in terms of allowing valid nutritional claims for foods and supplements such as raspberries and broccoli vies-a-vie cancer and folic acid and birth defects, it would be in the best interest of the consumer to be able to have access to “reasonable” claims – even before such claims have been fully validated by scientific studies. Treating foods and supplements like drugs in terms of allowing health claims is not economically viable as the millions of dollars required for testing can never be recovered through the sale of non-patentable products. It just leads to the suppression of ultimately valuable health information.
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 should be SIMPLIFIED and STANDARDIZED. The requirements are fundamentally different for products that may have harmful side effects and products that just may have unproven benefits. For those, consumers can try them and evaluate their efficacy for themselves. If there is no harm, let the marketplace determine the value. Think how many people would have benefited from this approach relative to folic acid, for example. The typeface can be smaller as long as it is readable.
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? Again, HARM is the operative word. Valid harmful effects must be identified. Nonsense “harmful” effects based on nonsense studies or reports such as those for L-tryptophan, DMSO, and Kava kava should not be promoted. Every time one of those is promoted it ultimately devastates the credibility of the FDA.
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? Legally, the case for distinguishing between labels and advertising is probably marginal. In practical terms, it makes more sense. Since “advertising” on labels is unchallenged, unreferrenced, and unexplained, it has much greater potential for misleading consumers.
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? Once again, the operative issue is HARM. Those products that have proven harmful side effects should not be as freely promoted as those that have no harmful side effects, but may not have proven benefits. Again, the market will eventually sort those 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? Absolutely not! Different standards are required for drugs with known harmful side effects, drugs with no known side effects, herbs and supplements that may have valid harmful effects (along with some benefits), and herbs and supplements that have no harmful side effects (along with possible health benefits). The current standards for potentially dangerous drugs are now far too lax. Witness the 2 million negative drug reactions and 106,000 deaths each year. And the current standards for herbs, foods, and supplements delays valid health information from reaching the public – often for years.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Doctors who work for the companies that manufacture drugs should not be part of evaluation process for approving the drugs. This is a dictionary definition of conflict of interest. Medical doctors, who by definition (read the AMA charter) have no knowledge of, and an antipathy for, supplements and herbs should not be the determining voice in approving their health claims. Again, it’s conflict of interest.




EC -28