Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -437

Accepted - Volume 6

Comment Record
Commentor Mr. Darren Burris Date/Time 2002-09-18 08:04:11
Organization Princeton Theological Seminary Student
Category Individual

Comments for FDA General
Questions
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? The FDA's position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health. In addition, the FDA should emphasize that commercial speech serves promotional purposes much more than educational ones. These promotional purposes do not deserve constitutional protection and -- even when not technically untruthful or misleading -- may by omission, emphasis or emotional appeal spur consumer purchasing patterns that are contrary to public health goals.
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 courts rationalize commercial speech protections on the grounds that commercial speech provides information to the public. If this is the goal -- rather than protecting an inherent right to advertise -- it makes sense for the government to make determinations about whether the commercial information actually will educate the public to advance public policy goals. In many instances, this will not be the case. And regulatory agencies are in better position to make such determinations than the courts.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? If there are going to be commercial speech protections, it should be enough for the FDA or other federal agencies to show that regulations reasonably work to directly advance legitimate governmental goals. The FDA and other agencies should not be subject to a least restrictive test, where they are forced to show that there was no less speech restrictive means to achieve their goal. One can always imagine less speech restrictive means -- even if they are politically unachievable or would fail to work in practice. Furthermore, Overly broad commercial speech protections will inappropriately transform legislative or regulatory decisions about public health issues into constitutional issues. (This is an argument Justice Breyer made in dissent in Western States Medical Center.)
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? I will say what I have already said about this issue. The FDA's position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health. The FDA should emphasize that commercial speech serves promotional purposes much more than educational ones. These promotional purposes do not deserve constitutional protection and -- even when not technically untruthful or misleading -- may by omission, emphasis or emotional appeal spur consumer purchasing patterns that are contrary to public health goals. The courts rationalize commercial speech protections on the grounds that commercial speech provides information to the public. If this is the goal -- rather than protecting an inherent right to advertise -- it makes sense for the government to make determinations about whether the commercial information actually will educate the public to advance public policy goals. In many instances, this will not be the case. And regulatory agencies are in better position to make such determinations than the courts. If there are going to be commercial speech protections, it should be enough for the FDA or other federal agencies to show that regulations reasonably work to directly advance legitimate governmental goals. The FDA and other agencies should not be subject to a least restrictive test, where they are forced to show that there was no less speech restrictive means to achieve their goal. One can always imagine less speech restrictive means -- even if they are politically unachievable or would fail to work in practice. Overly broad commercial speech protections will inappropriately transform legislative or regulatory decisions about public health issues into constitutional issues. (This is an argument Justice Breyer made in dissent in Western States Medical Center.) Because corporations should not have any constitutional protections, and because commercial speech should not receive constitutional protection, the FDA should press as hard as possible against existing limitations in these areas.
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? Whatever the alternative regulation, the FDA should firmly remain separated from corporate abuse of their problematic First Ammendment rights status. The FDA should give primacy to the individual constituent and govern the restrictions on speech according to the standard rather than corporate standards.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Fist and foremost, corporations and commercial speech should have no constitutional protection; however, I recognize that the provision do currently exist via court decisions. Therefore the appropriate response of the FDA is to push as hard as possible against the limits of these misguided constitutional protections.




EC -437