Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -369

Accepted - Volume 6

Comment Record
Commentor Mr. Brian Seymour Date/Time 2002-09-09 13:31:26
Organization Mr. Brian Seymour
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? Drugs for the most part have MANY more side effects than dietary supplements. FDA should not grant the right to Drug Companies to market misleading or false claims. FREE SPEECH IS THE RIGHT OF PEOPLE NOT COMPANIES!
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? There have been many studies that have pointed to marketing-related diseases, such as childhood obesity and type 2 diabetes. Giving blanket First Amendment rights to companies to advertise will only increase our vulnerability (and our most at risk members of our population: our children and our elderly) to more of these types of diseases.
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? Yes. It must be of equal volume (or type font) as the rest of the add.
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? See above.
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? First Amendment rights must be given to individuals ONLY.
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? DO NOT allow Corporations First Amendment rights! This is NOT the intent of the Constitution or the framers of the Constitution.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I strongly feel that the framers of the Constitution did not intend Corporations to be given the rights of citizens! Corporations should not be given First Amendment protections because ordinary citizensí voices will be drowned out with their dollars. I am strongly opposed to the extension of rights given to people to Corporations and other non-existent entities. This is a gross distortion of our Constitution. There are many times when the voices of Corporations, especially lies in constant commercials, must be silenced for the good of public health and to protect our children. The FDA should be protecting us from these deceptions, not promoting the rights of Corporations to deceive us. I am intensely opposed to our government giving the Constitutional rights to Corporations!!

EC -369