Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -134

Accepted - Volume 2

Comment Record
Commentor Dr. Brian Carson Date/Time 2002-06-18 11:15:14
Organization Carson Imaging Incorporated
Category Health Professional

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? yes they are more comprehensive, yes it can be misleading whenever vested intrests voice such 'speech', the FDA should (funded by tax dollars) never be influenced by vested interests, and finally consumers are not stupid ginnea pigs; THEY SHOULD BE INFORMED TRUTHFULLY.
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? VESTED INTERESTS should not be allowed to advertise, nor should they be allowed to get FDA approval and refine their product based on the larger database provided by a large consumer base. Microsoft publishes it's operating systems befor all the bugs are worked out and they rely on a huge consumer database of error reporting to refine their product DRUG COMPANIES SHOULD NOT BE ALLOWED TO DO THE SAME.
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? Common sense is said to be the rarest commodity on Earth, so lets use it auspiciously and with enthusiam.
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? All information should get equal billing; Not doing so exponentially increases the authors ability to use graphics to mislead the consuner. But, warnings and danger to children shold be emphasized clearly!
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? Common sense: tell them what it can and cannot do.
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? The government should impose the most stringent labeling requirements promoting truthfullness. If lobbists for vested interests find this, inhibiting their profit margin, they should be divested. The consumer should be protected at all costs, AND they pay your salaries.
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 should be discouraged.
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? When the FDA is not being bullied by self serving interests, it does a fair job. The FDA should strive for unbiased Excellence! Make it impossible for a company to use labeling to earn a large profit at the expense of the consumer. Look at the fear of the common cold promoting unparrelleled use of major durg co. products and the products of the suppliments industry.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Any company raping a rain forest for a patent on a molecularl modification should be ground up and used as farm fertilizer: every 3.6 seconds somebody dies of starvation and you are asking how can we regulate? Just do it and do it with vim and vigor!!

EC -134