[Federal Register: May 16, 2002 (Volume 67, Number 95)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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,
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.
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
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
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.
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
Dated: May 13, 2002.
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 02-12325 Filed 5-13-02; 4:53 pm]
BILLING CODE 4160-01-S