Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -355

Accepted - Volume 6

Comment Record
Commentor Mrs. Catherine Bath Date/Time 2002-09-06 15:23:44
Organization Security On Campus, Inc.
Category Other

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? speech of large corporations should be reined in for the following reasons: they use clever and thoroughly researched tactics to convince average Americans to use their products. Often these products are harmful and addicting drugs - Also, the individual cannot compete with the speech of corporations. They have the finances to buy the ear of decision makers. NOT FAIR
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 drugs gives the average person the impression that the drug will help them. (whether in reality it may or may not) At least prescription drugs need to give verbal warnings of side effects when they advertise. Not that a person can understand what they are saying because they are speaking at such a fast pace! Alcohol, a very dangerous and addictive drug has NO WARNINGS AT ALL! The alcohol industry, like the drug industry is so cash rich that they control many government decisions - and decisions which favor corporations over individuals needs are harmful to society at large.
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 given equal prominence of course
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? good consumers read all warnings and take them into consideration. Truth should not be kept from the consumer just to sell a drug
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? yes, the gov. should have great latitude over labels. At least information should be presented truthfully and factually. Not slanted in the interest of unhealthy consumer consumption.
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? speech of corporations should be restricted when common wisdom shows they are promoting products to make money rather than enhance the life of the consumer.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? corporations should not be allowed to advertise dangerous and addictive drugs (such as alcohol) If they do advertise them, there should be clear and prominent warnings of all the dangers.

EC -355