[Federal Register: May 16, 2002 (Volume 67, Number 95)]
[Page 34942-34944]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 02N-0209]

Request for Comment on First Amendment Issues

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is seeking public 
comment to ensure that its regulations, guidances, policies, and 
practices continue to comply with the governing First Amendment case 
law. Recent case law has emphasized the need for not imposing 
unnecessary restrictions on speech. FDA believes this action will help 
the agency continue to protect the public health, while giving full 
recognition to evolving judicial decisions.

DATES: Submit written or electronic comments on this notice by July 30, 
2002. Responses to those comments must be submitted by September 13, 

[[Page 34943]]

ADDRESSES: Submit written comments to the Dockets Management Branch, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/

FOR FURTHER INFORMATION CONTACT: Catherine Lorraine, Office of Policy, 
Planning, and Legislation (HF-11), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3360.


I. Background

    FDA is committed to protecting the public health as well as to free 
and open communication. Recent years have witnessed increased attention 
by consumers to their own medical care. The public's interest in, and 
access to, useful and truthful information about medical products have 
skyrocketed. This generally positive development presents unique 
challenges to the FDA, which regulates a wide range of both products 
and words.
    FDA has historically employed its authority to ensure, to the 
extent possible, that health care professionals and consumers receive 
accurate and complete information. The manner and substantive content 
of FDA's regulation of speech has important implications for public 
health. False or misleading claims concerning foods, drugs, biologics, 
medical devices, cosmetics, or veterinary medicines may harm 
individuals who rely on those claims. Truthful claims, by contrast, may 
improve public health. At the same time, advertising may have indirect 
effects on public health. If advertising of prescription drugs, for 
instance, leads to better informed consumers or to more physician 
visits to treat under-diagnosed illnesses, more people will be better 
off. On the other hand, if advertising of prescription drugs results in 
the inappropriate prescription of pharmaceuticals, the effect on public 
health will be negative.
    The Supreme Court has increasingly recognized the value of speech 
proposing a commercial transaction, which it calls ``commercial 
speech'' and which is entitled to First Amendment protection so long as 
it is truthful and not misleading. This case law presents a challenge 
to FDA. FDA must balance the need and right of Americans to speak and 
hear information vital to their every day lives against the need to 
ensure that people are not misled. The importance of FDA vigilance is 
heightened given the nature of many of the products FDA regulates, some 
of which are extremely complex and which have the potential to harm as 
well as help.
    There may be tension between some aspects of FDA's authority and 
judicial developments. Some statutory provisions that FDA enforces 
explicitly limit speech. Indeed, much of the operation of the Federal 
Food, Drug, and Cosmetic Act (the 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.
    As recently as April 2002, however, the Supreme Court struck down 
as violative of the First Amendment legislative authority for the FDA 
to restrict advertising of particular compounded drugs. (Thompson v. 
Western States Medical Center , 535 U.S. _, No. 01-344 (April 29, 
2002)). In that decision, the Court said that even assuming that the 
restriction on speech directly advanced the Government's important 
interest in maintaining the integrity of FDA's new drug approval 
process, that interest could have been attained without imposing such 
restrictions. Lower courts have also held that the FDA must adhere to 
the First Amendment's guarantee of free speech. Not only have some of 
these decisions thwarted actions FDA has wished to pursue, however 
beneficial as matters of public policy, but they may threaten to 
diminish the overall legal credibility necessary for FDA to sustain its 
authority to accomplish its important public health duties.
    FDA must continue to pursue regulation of products for purposes of 
protecting the public with a full recognition of the evolving judicial 
landscape in areas that directly affect its ability to regulate words. 
To be sure, FDA will continue to regulate commercial speech as part of 
its mandate. In particular, FDA intends to defend the act against any 
constitutional challenges, as it did in the Western States case. FDA 
seeks to ensure, however, that its regulations, guidances, policies, 
and practices comply with the First Amendment. 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.
    To that end, FDA seeks comment on these and other issues related to 
the FDA's regulation of commercial speech. To facilitate this 
discussion, FDA sets forth some questions below. These questions are 
not meant to be exhaustive. Rather, they are meant to spur the public 
to provide FDA with comments that will help FDA safeguard the public 
health while fulfilling all its legal obligations. The public is 
encouraged to address these and/or other related 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

[[Page 34944]]

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 
    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 
    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?
    FDA is requesting comments within 75 days. Parties will then be 
given 45 days to reply to the comments of others. Parties are 
encouraged to share comments among themselves.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this notice by July 
30, 2002. Responses to those comments must be submitted by September 
13, 2002. Two copies of any written comments are to be submitted, 
except that individuals may submit one copy. Submit one electronic 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: May 13, 2002.
William Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 02-12325 Filed 5-13-02; 4:53 pm]