Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -24

Accepted - Volume 1

Comment Record
Commentor Ms. Lila Berman Date/Time 2002-05-28 21:44:15
Organization Ms. Lila Berman
Category Individual

Comments for FDA General
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 for prescription medicine should be banned. It puts pressure on the doctors to prescribe a medication they may not think is best for the patient. If they don't prescribe, the patient may go elsewhere. Through the power of color TV, the ads portray the drugs as the answer to your prayers which is very mnisleading. Mentioning the risks seems to go over most people's heads -- they think the side effects will happen to someone else, but not them.
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? Of course disclaimers should be in as large type as the claim. After all, common and rare side effects are as real as the claimed benefits.
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 do not confuse consumers, they tell the truth. Side effects do happen to many people and it is dishonest not to let the consumer know this loud and clear. I think the FDA is more concerned about the drug company's profits than the consumers confusion.
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? Claims are claims and, if evidence exists to support them, should be allowed on labels or in ads.
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? Yes, the FDA could prove the falseness of a claim and then get the claims banned, or the product off the market if it is shown to be harmful. Old evidence could be cited to do the same. But there needs to be real evidence of the claim's falseness. Conversely, there must be real evidence of the product's efficacy for the company to be allowed to make any claims.

EC -24