Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -326

Accepted - Volume 4

Comment Record
Commentor Ms. Heather Cushman-Dowdee Date/Time 2002-09-05 11:25:08
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? I believe there are arguments for regulating speech when it takes on a commercial nature. Whenever a corporation (by its nature is not a person, even if it has a person at the helm)takes protection under first ammendment rights, they are trampling on the rights of individual people. All promotional speech about drugs is inherently misleading, the only time it is not is when you are engaged in an informed discussion with your private doctor, but because it can't be ascertained whether your doctor has recived promotional bribes from the corporations, even this speech is suspect.
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? I believe there are horrible consequences of the protections pharmaceutical companies now enjoy in their right to promote their products. Foremost is the pathologizing of life. Advertising by its nature is not a good way for people to learn, it treats humans as empty vessels who should be filled by information.
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.
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 first Ammendment does not protect corporate speech, therefore the Government(as the collective voice of the people) has the right to control content of labels and advertising for products.
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? yes. they should be regulated. If people want to make informed decisions about alternative uses and therapies they can access books, and studies to find the information.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should honot the freedoms of the people over the free speech rights of fictional entities. As a parent I expect the Foods and drugs my children use will be safe, but I also want the use of these products to be at my discretion. Excessive advertising and promotion undermines my parental and human authority, and should be placed under much tighter controls.

EC -326