Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -338

Accepted - Volume 4

Comment Record
Commentor Mrs. Emily Dale Date/Time 2002-09-05 15:34:02
Organization Dale Enterprises
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? This is not advertising tomatoes or soap. This is advertising products that often contain dangerous elements and which may have harmful side effects, or which may not be used in combination with other pharmaceuticals. Any promotional speech about drugs should be limited to health professionals and pharmacists.
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? The billions of dollars pharmaceutical companies spend on advertisement of their products could be better spent by reducing the inflated cost to the consumer of those products. When pharmaceutical companies had a product to market in the past, they made every effort to fully instruct physicians on the merits of the product. Now, in taking their case directly to the public, they are circumventing this important step in order to increase volume sales, thereby putting the uninstructed consumer at risk. There is no way that one page of advertisement can tell the full story about a drug product. Consumers are lured by the attractive full-color background of the ad and the language that insists they need the pharmaceutical for their sympton without reading fully the small-print caveats. They then insist that their health practitioner prescribe the product, even though the practitioner may not be fully apprised of the product information. This is NOT protecting the consumer.
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? Dietary supplement claims are fully supervised by the FDA and are not pharmaceuticals. Most are food-derivatives, along with herbals (also originating from nature). Only those claims that have been supported by clinical tests in the U.S. or other nations recognized for their high standards relating to same can be advertised as relating to the product. Side effects, if any, are noted, and they are so minimal that they do not require the full-page small-print warnings that accompany the advertisements for most pharmaceuticals that have so many side effects. Consumers are becoming more aware of the difference in conventional foods with the usage of GMOs, hormone introduction, pesticides, insecticides and chemical fertilizers in everyday products. Claims that a conventional food is beneficial to one's health are called into question when its growth and processing include those. As a contrast, organic foods are where product quality and content are carefully monitored and regulated by a set of high standards. Conventional foods should show qualifications or disclaimers so that consumers may be informed of their content. Dietary supplements, being food for the most part, should also show qualifications or disclaimers if there is evidence of GMOs, pesticides, insecticides or chemical fertilizers involved in their production along with any nutritional or health benefit that may be derived from their consumption.
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? Absolutely. They should be in the same size of type and be given equal prominence. That goes for pharmaceuticals as well, which show disclaimers in minimal font size that is difficult to read.
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? Warnings should refer to products not to be used when taking the product in question. It should list the health-related conditions where taking the product is not advisable. It should refer consumers who may be confused to their Health Practitioner for advice whether or not to use the product.
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? Labels cannot contain all information, but supplemental data in a leaflet enclosed with the product can do so.
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? The First Amendment is quite clear when it comes to speech regarding off-label uses or anything else. The FDA cannot regulate speech in this regard. I can tell a neighbor who has arthritis that I have been taking certain products that cleared the condition (even though the labels did not make this claim), and I have the freedom to do this. Therefore, if a manufacturer, distributor or marketer makes certain verbal claims for off-label uses and there are valid reasons that this can be supported even though it is not the primary purpose of the product, then the FDA is not empowered to step in.
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? Not necessarily. The FDA is too political an organization ever to have a broad viewpoint on the subject of freedom of speech. It is heavily weighted on the side of the pharmaceutical and chemical companies. It should have shown more concern for the consumer years ago when dangerous chemicals were allowed to be used in food production and when genetically-modified organisms were utilized to change the dna of food products to make them more attractive to the consumer. Nothing was said about being healthier. As a result, we have bright red tomatoes that have salmon genes in them to make them red before they are ripe, but have no taste and are like cannonballs. We have poultry that are given hormones to make them grow faster, or produce eggs more rapidly, and who are housed in conditions where they never have darkness or touch the earth, and are highly stressed, which taints the meat. Our meat is given feed that contains meat by-products (they are not carnivores), hormones to make them gain weight faster and fattened up in feed lots that are disgusting to see. And this is overseen by the FDA???

EC -338