Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -225

Accepted - Volume 4

Comment Record
Commentor Mrs. Cynthia Ayers Date/Time 2002-07-26 17:41:14
Organization Mrs. Cynthia Ayers
Category Health Professional

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? Docket Management Comment Form Docket: 02N-0209 - Request for Comment on First Amendment Issues Enter your comments below. 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? The FDA should stringently regulate pharmaceutical drugs, including, but not limited to, making the public verbally & in writing, aware of the toxic potential of these drugs. It should NOT be in the FDA's sphere of influence ANY dietary supplements. These products are food - what's next - will the FDA regulate broccoli? The creation of the FDA was to monitor & issue LD50 ratings on toxic pharmaceutical drugs. Indeed this roll is important. However, it SHOULD not be their roll to in ANY way involved with the dietary supplement sector. 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? Again, it is not, and should not, be the function of the FDA to play big brother to the consumer or the patient. A patient-doctor relationship is separate from governmental regulation. If a disease is under diagnosed, that is the problem of the physician & of course, the patient. The FDA's responsibility needs to cease at the label!! 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? NO, NO, NO - FDA may not distinguish claims between foods and dietary supplements! This is not an area of concern for them. Because of the DSHEA Law, consumers now have the opportunity to do their own due diligence regarding pertinent research & viability of dietary supplements. If a consumer chooses NOT to become informed, that is indeed THEIR responsibility, NOT the FDA's - not anymore so than if a consumer makes a poor choice with seatbelts, speed limits, bike helmets, smoking, or use of alcohol. Consumers who are motivated to explore claims whether it be about foods or supplements WILL find the information they want via reputable companies. 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? NO. Disclaimers, which are unnecessary, fall on deaf ears (or eyes) for consumers who do not care or who don't want to explore. For consumers who are motivated to learn more, should be directed via the label to scientific data available via the internet or local library. Who knows if there is any relevant authority on this issue? More importantly, who cares?? It is strikingly obvious that consumers to not heed disclaimers unless so motivated. Take for example the tobacco industry!!! It cannot be more evident that smoking/chewing causes cancer; yet consumers choose to do so. It is the RIGHT of the consumer to make choices - regardless of whether or not an agency in Washington DC thinks otherwise! 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? This is redundant. A warning or disclaimer is just that. Let the consumer make their own choices. I clearly see the next step as an FDA agent standing at the ice cream or pretzel aisle in the grocery store, saying - now fat & salt aren't good for you. . . . 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? Without knowing line & verse of the law, manufacturers should be allowed to claim in advertisements and on lables, information for which they have scientific backing. 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? Your use of off-label has no meaning. Unable to comment. 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? The FDA should monitor pharmaceutical companies and the labeling laws concerning the demonstrated amounts of nutrients. All other activities should be grossly restricted. 9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? As stated in #8, the FDA needs to monitor what they have already been assigned to do! The fact that approved additives such as aspartame CONTINUE to be allowed in our food supply is unbelievable given the amount of research indicating its' contribution to various disease states. SO, if the FDA quit worrying about keeping pharmaceutical companies in the FDA's back pocket, & REALLY being concerned about public health, this would keep them quite busy enough. Let consumers make their choices!




EC -225