FDA Seeks Public Comment on First Amendment Boundaries for Health Claims

WASHINGTON--In the face of losing a Supreme Court decision about its authority in applying the First Amendment to health claims, the Food and Drug Administration (FDA) is requesting public comment regarding its practices in regulating claims for the food, drug and dietary supplement industries. The notice appears in the May 16 Federal Register (www.access.gpo.gov) and poses nine questions for public comment within 75 days.

"The agency now is going to have to come up with some kind of coherent test, a set of standards, that is going to apply when it suppresses protected speech," said Marc Ullman, partner at New York's Ullman, Shapiro & Ullman. "And in doing this, they are soliciting public comment on how to develop these standards."

The Supreme Court, according to FDA, recognizes the value of commercial speech, which is entitled to First Amendment protection as long as it is truthful and not misleading. FDA reported that this presents a challenge for the agency. "Some statutory provisions that FDA enforces explicitly limit speech. Indeed, much of the operation of the Federal Food, Drug and Cosmetic Act depends on the use of words, such as whether a product is marketed along with claims that it can affect the structure or function of the body of man, or treat disease," wrote the author of the notice, William Hubbard, senior associate commissioner for policy, planning and legislation.

As recently as April, the FDA was challenged by the judicial system for violating the protection proffered under the First Amendment. In Thompson v. Western States Medical Center, FDA attempted to restrict advertising related to particular compounded drugs; however, the Supreme Court ruled that FDA must adhere to the tenets under the First Amendment. "Not only have some of these decisions thwarted actions FDA has wished to pursue--however beneficial as matters of public policy--but [these decisions] may threaten to diminish the overall legal credibility necessary for FDA to sustain its authority to accomplish its important public health duties," Hubbard wrote.

In the Federal Register the agency wrote it will continue to regulate commercial speech as part of its mandate and will continue to defend itself against any constitutional charges, as it did during the compounding drugs case. "FDA seeks to ensure, however, that its regulations, guidances, policies and practices comply with the First Amendment," Hubbard continued. "FDA also wishes to learn what empirical evidence exists concerning the effect of commercial speech on the public health, and whether its regulations in this field in fact advance public health."

Ullman noted that FDA's power to limit commercial speech is only applicable with valid explanation. "Commercial speech has to be truthful and not misleading in order to be protected," he explained. "If the speech is truthful and not misleading, then FDA can only suppress it if it can elucidate a compelling public health interest for doing so. ... They've had these three losses, and it is now very clear that the federal courts are going to apply standard commercial free speech analysis."

FDA's Nine 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?

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?

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?

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?

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?

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?

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?

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?

9. Are there any regulations, guidance, policies and practices FDA should change, in light of governing First Amendment authority?

Submit written comments to the Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments at www.fda.gov/dockets/ecomments. Comments are due by July 30, 2002, and responses to those comments must be submitted by September 13, 2002.