Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -444

Accepted - Volume 6

Comment Record
Commentor Ms. Marsha Cohen Date/Time 2002-10-28 22:00:37
Organization Ms. Marsha Cohen
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? FOLLOWING IS THE TEXT OF MY COMMENTS IN THEIR ENTIRETY: 200 McAllister Street San Francisco, CA 94102 October 28, 2002 Dockets Management Branch Food and Drug Administration Submitted electronically Docket No. 02N-0209 Comment on First Amendment Issues Dear Madam or Sir: I am a law professor who has long been involved in food and drug policy issues. I was a staff attorney many years ago for Consumers Union in Washington, DC, and I have been a member of a number of FDA advisory committees, National Academy of Sciences study groups, and the like. I served for almost eight years as a member of the California State Board of Pharmacy, and am co-author of a textbook on California pharmacy law. I fear that policy choices, abetted by unfortunate court decisions, threaten to return us to the era of the snake oil salesmen. It is the Food and Drug Administration’s obligation to seek to uphold regulatory choices made by the United States Congress, not to tear them down. First Amendment challenges to agency regulatory programs should be met by a strong defense. The agency has not done nearly enough to muster such a defense. Under the Supreme Court’s decision in Central Hudson Gas & Electric Corp. v. Public Service Commission of New York, 447 U.S. 557 (1980), the government has an obligation to justify regulatory restrictions that can be viewed as restrictions upon speech. It cannot sit back and just argue, at the time of challenge, that its restrictions are necessary to advance important government interests and that less restrictive alternatives are unavailable. We have seen that such an approach has not been convincing to members of the judiciary, who are often quite unfamiliar with the problems of the regulatory schemes involved. The FDA needs to gather the data to demonstrate the importance of these regulatory restrictions in the context of consumer protection. Has the agency been engaged in a vigorous program of consumer studies, focus groups, and the like to demonstrate why certain types of restrictions are necessary? One example involves product labels. I believe that the label is considered by consumers as “regulated space” upon which they may rely for accurate, government-approved information. Disclaimers are, I believe, ineffective in conveying the fact that information preceding them is entitled only to the credibility afforded other types of promotional materials. I have no social science evidence; it is FDA’s role to do the studies to find data to determine what consumers believe, and to what extent changes in the sanctity of the product label have led to consumer confusion. Some restrictions that are challenged as preventing speech do not prevent speech at all. Much FDA regulation is based upon product definitions which are heavily influenced by the intention of the product seller. What is said about products often is directly relevant to drawing definitional boundaries. No speech is prevented by this type of regulation – the speaker simply must comply with the requirements of the product category. FDA should be studying what it must do to demonstrate, factually and legally, that determining boundary lines in part by what is said about products is constitutionally appropriate. FDA’s failure to provide factual data to support the need for regulation that some consider infringement on their First Amendment rights, in accordance with the law governing commercial speech, has led in significant part to today’s predicament. FDA’s notice concerning this proceeding asks many questions about evidence that can be used to support this or that. Consumer organizations cannot create that evidence. Industry groups will seek evidence to support their deregulatory agendas. It is the government’s role to do the research to support the regulatory system that has long protected the American people, rather than to ask for a laundry list of regulations that regulated industry would like to disappear. Very truly yours, Marsha N. Cohen Professor of Law Hastings College of the Law University of California

EC -444