Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -357

Accepted - Volume 6

Comment Record
Commentor Mr. Charles Dunaway Date/Time 2002-09-06 17:02:45
Organization Mr. Charles Dunaway
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? There are no arguments against regulating commercial speech either about drugs or dietary supplements that should merit consideration by the Agency. Speech by corporations was never meant to be protected by the First Amendment, only speech by citizens. If the FDA is unwilling to regulate commercial speech about prescription drugs, it is failing in its duty to protect the American people from misinformation and misuse of pharmaceuticals. All commercial statements about a drug regardless of the intendend audience should be subject to FDA regulation - no distinction needs to be made between learned intermediaries and consumers. The FDA has an absolute right and duty to regulate commercial speech about pharmaceuticals.
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? The current lax regulatory approach, particularly in regard to commercials that target consumers directly, leads to over-prescription of drugs. It may lead to self-misdiagnosis and misleading of physicians, and induce physicians to prescribe without appropriate examination and diagnosis. I would urge the FDA to ban direct-to-consumer advertising of prescription drugs outright.
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 First Amendment does not inhibit the government's right to regulate commercial speech either on advertisements or labels. No distinction is necessary.
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? Advertisers should not be permitted to refer to off-label uses of drugs in any way in commercial speech. The FDA has no limit on it's Constitutional ability to regulate this speech.
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 does not and has not ever restricted the free speech of American citizens. The Agency should have no qualms whatever about restricting the commercial speech of drug advertisers when the public health is involved.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should change any regulations and policies that serve to curtail its ability to regulate commercial speech.

EC -357