Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -279

Accepted - Volume 4

Comment Record
Commentor Mr. Sam Prestwich Date/Time 2002-07-30 02:06:16
Organization Mr. Sam Prestwich
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? Why does something have to be classified as a drug before it can be used to treat a disease? Vitamin C (limes) has been used successfully for centuries to treat and prevent disease. Require any advertisement or discussion of a drug or food supplement to contain any of it's known negative side effects or report the intake level at which negative side effects begin to appear. This could equalize the playing field. To much vitamin C can also cause problems and consumers should be informed on how much begins to be too much. What health conditions can oranges reverse, how many (range) can I eat before negative problems start to appear and what are they? One company avoided educating the consumer about potential risks of their product by creating two advertisements that suggested a benefit and never actually stated the positives or negatives (it was a pharmaceutical and I thought it was very clever and underhanded).
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? Anytime something is advertised to consumers, consumption will increase. Do we want more people on drugs? I think toxic substances requiring medical expertise to administer should not be publicly advertised. Toxic substances should only be advertised in professional journals and direct mailing to learned intermediaries. This will help the situation where individuals are telling medical professionals what the patient needs and going to another doctor if they don't get it like recent diet and erectile dysfunction drugs. Perhaps generic advertisements could be made by interested companies to target under-diagnosed diseases. This would move patients to doctors to purchase treatments. Indirect sales would be made. Professional journals and mailings would educate and encourage medical professionals to identify diseases and prescribe appropriate remedies.
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? Let the public know if a particular food is proven to have health benefits . Just because my meal has vitamin C as an ingredient does not lead to the conclusion it can prevent or reverse disease or is even healthy. The actual product must have third party validation that it has healing properties and if claims are made, negative effects should be listed with the positives by anyone selling, or prescribing it.
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? Current practices are acceptable.
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? Instead of listing all or even most noticable negatives in an advertisement, identify the severity of side effects only. Develope catchy, unique symbols. Products with more severe or numberous side effects could have more noticable warning symbols. For dietary supplements, the level of consumption at which negative side effects begin to appear could be listed.
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? Major positive and negative facts should be in all advertisements of known drugs and products intended to be used to treat illness and disease. All known specifics should be provided (website) to the consumer at the time of sale. I feel current labeling practices are good.
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? Off-label uses are impossible to regulate. A consumer is going to listen to anecdotal information. Consumers are intelligent enough to know the difference. The problem comes when all they have is the anecdotes. They see or hear about an obvious benefit and after time decide there is a conspiracy to hide the truth (is there?). The main problem is that uses for a product are not printed along with potential negatives. Individuals often witness off-label benefits, but the side effects have not been studied. If a product has abilities to fight illness and disease, allow manufactures to print (flyers, internet, etc.) what people already know along with a risk assessment of potential negative side effects. The problem is what's not printed or explained.
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? Focus on what will most educate the public so they can make wise choices. Consumers will buy whatever they want from wherever they can get it. In my opinion, education about products is the key.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Move more in the direction DSHEA has taken us. Enforce more education about products. All information known about a product should be available in language a consumer can understand. Encourage the first amendment and discourage the fifth. Companies and individuals working with a persons health should tell the whole truth and leave nothing hidden.

EC -279