[Federal Register Volume 60, Number 158 (Wednesday, August 16, 1995)]
[Notices]
[Pages 42581-42584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20314]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0227]
Direct-to-Consumer Promotion; Public Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
hearing regarding direct-to-consumer promotion of prescription drugs.
The purpose of the hearing is to solicit information from, and the
views of, interested persons, including health care professionals,
scientists, professional groups, and consumers, on the issues and
concerns relating to the promotion of prescription drug products
directly to consumers through print, broadcast, and other types of
media. FDA is particularly interested in hearing the views of the
groups most affected by direct-to-consumer promotion, including
patients, caretakers, physicians, physicians' assistants, nurses,
pharmacists, managed care organizations, and insurers.
DATES: The public hearing will be held on October 18, 1995, from 8:30
a.m. to 5:30 p.m., and October 19, 1995, from 8:30 to 12:30 p.m. Submit
written notices of participation by September 15, 1995. Written
comments will be accepted until December 29, 1995.
ADDRESSES: The public hearing will be held at the Quality Hotel--Silver
Spring, 8727 Colesville Rd., Silver Spring, MD. Submit written notices
of participation and comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with docket number 95N-0227. Transcripts of the hearing will
be available for review at the Dockets Management Branch (address
above).
FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4695.
SUPPLEMENTARY INFORMATION:
I. Background
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has
responsibility for regulating the labeling and advertising (promotional
activities) for prescription drugs. Under section 201(m) of the act (21
U.S.C. 321(m), labeling is defined to include all ``written, printed,
or graphic'' materials ``accompanying'' a regulated product. The
Supreme Court has agreed with the agency that this definition is not
limited to materials that physically accompany a product. The Court has
deemed the textual relationship between the materials and the products
to be fundamental (Kordel v. United States, 335 U.S. 345, 349-350
(1948)). In its regulations, FDA has given examples of things that it
regards as labeling, including brochures, mailing pieces, calendars,
price lists, letters, motion picture films, sound recordings, and
literature (Sec. 202.1(l)(2) (21 CFR 202.1(l)(2)). Although the act
does not define what constitutes a prescription drug ``advertisement,''
FDA generally interprets the term to include information (other than
labeling) that is sponsored by a manufacturer and is intended to
supplement or explain a product. This includes, for example,
``advertisements in published journals, magazines, other periodicals,
and newspapers, and advertisements broadcast through media such as
radio, television, and telephone communication systems''
(Sec. 202.1(l)(1)).
If an activity or material is considered to be either advertising
or labeling, it must meet certain requirements. Labeling must contain
adequate directions/information for use that is the ``same in language
and emphasis'' as the product's approved or permitted labeling (21
U.S.C. 352(f)) and 21 CFR 201.100(d)). This requirement is generally
fulfilled by including the full approved labeling for the product (the
``package insert'') with the promotional materials. The act specifies
that, in addition to the identity of the product and its quantitative
composition, advertisements must contain ``other information in brief
summary relating to side effects, contraindications, and effectiveness
* * *''(21 U.S.C. 352(n)). FDA further defines this latter requirement
in Sec. 202.1(e). This requirement is generally fulfilled by including
the sections of the approved labeling that discuss the product's
adverse event profile, contraindications, warnings, and precautions. In
addition, the act and regulations specify that drugs are deemed to be
misbranded if their labeling or advertising is false or misleading in
any particular or fails to reveal material facts (21 U.S.C. 352(a) and
321(n) and Sec. 202.1(e)).
A. History of Direct-to-Consumer Promotion
The practice of promoting prescription drug products directly to
consumers began to gain popularity in the early 1980's. Until that
time, drug
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manufacturers had typically limited their promotion to health care
professionals. With the onset of direct-to-consumer promotion, the
effectiveness of the regulatory scheme, was called into question.
To explore the ramifications of direct-to-consumer prescription
drug promotion, FDA requested a voluntary moratorium on this practice
in a September 2, 1983 policy statement. During the moratorium, FDA
sponsored a series of public meetings and conducted research. In 1984,
a symposium, jointly sponsored by the University of Illinois and
Stanford Research Institute (SRI), was held to discuss consumer-
directed prescription drug advertising from a broad research and policy
perspective. In the Federal Register of September 9, 1985 (56 FR
36677), the moratorium was withdrawn in a notice, which stated that the
current regulations governing prescription drug advertising provide
``sufficient safeguards to protect consumers.''
Since 1985, FDA has applied the act and the prescription drug
advertising regulations to both professional and consumer-directed
promotion on a case-by-case basis. There are no regulations that
pertain specifically to consumer-directed promotional materials. FDA
recognizes and accounts for the differences between health care
professionals and consumers as recipients of drug promotion, such as
differences in medical and pharmaceutical expertise, perception of
pharmaceutical claims, and information processing. For this reason, FDA
has monitored direct-to-consumer promotion to help ensure that adequate
contextual and risk information, presented in understandable language,
is included both to fulfill the requirement for fair balance and to
help the consumer accurately assess promotional claims and
presentations. Additionally, in a July 1993 letter to the
pharmaceutical industry, as well as in numerous prior and subsequent
public presentations given by FDA staff, the agency has requested that
drug manufacturers voluntarily submit proposed direct-to-consumer
promotional material prior to use, allowing FDA the opportunity to
review and comment upon proposed materials before they reach consumers.
B. Current Issues in Direct-to-Consumer Promotion
1. General
The repercussions of direct-to-consumer promotion have been widely
discussed. Proponents argue that direct-to-consumer promotion is of
educational value and will improve the physician-patient relationship,
increase patient compliance with drug therapy and physician visits, and
lower drug prices. Opponents contend that consumers do not have the
expertise to accurately evaluate and comprehend prescription drug
advertising. Opponents also argue that such promotion is misleading by
failing to adequately communicate risk information, and that such
promotion will damage the physician-patient relationship, increase drug
prices, increase liability actions, and lead to over-medication and
drug abuse. Rigorous studies are needed to assess the actual effects of
direct-to-consumer promotion and to help guide future policy.
In the last few years, FDA has received a number of citizen
petitions that address direct-to-consumer promotion. The positions
advocated by these petitions vary considerably. One petition requests
that FDA ban direct-to-consumer advertising of prescription drugs. A
second petition requests that FDA not adopt or institute any
significant new restrictions to existing regulations nor mandate prior
approval of consumer-directed advertising. A third petition, recently
updated and reissued by the petitioner, contends that consumer-directed
prescription drug advertising should not be regulated under Sec. 202.1,
and it also contends that FDA should promulgate new regulations to
address prescription drug advertisements directed to consumers. The
petitioner further contends that, until such time as new regulations
are established, FDA should issue a policy statement that prescription
drug advertisements directed to the general public are exempt from the
advertising regulations. Another petition, recently received by FDA,
reiterates these concerns and also raises First Amendment issues. The
range of actions requested in these petitions is indicative of the
diversity of views regarding direct-to-consumer promotion. FDA
recognizes the importance of the issues raised by these petitions, and
FDA intends that one of the purposes of the public hearing will be to
assist the agency in responding to these petitions.
2. Types of Direct-to-Consumer Promotion
There are three broad categories of direct-to-consumer promotion of
prescription drugs: (1) ``Product-claim,'' containing safety and
efficacy claims about a particular drug(s); (2) ``help-seeking,''
containing information about a disease or condition and a
recommendation for the consumer to consult a health care provider, when
appropriate, while excluding discussions of specific treatments or
drugs; and (3) ``reminder,'' containing the name of the drug and other
limited information, but excluding all representations or suggestions
about the drug(s).
3. Product-Claim
Product-claim promotional materials contain safety and efficacy
claims about a specific prescription drug product. The regulations
require that these materials present a balanced view of the drug
(Sec. 202.1(e)(5)(ii)). Claims of drug benefits, such as safety and
efficacy, must be balanced with relevant disclosures of risks and
limitations of efficacy. This balanced presentation of drug therapy is
commonly referred to as ``fair balance.''
Currently, most consumer-directed product-claim materials are
limited to one drug product and do not compare drugs, or classes of
drugs, with each other. Proponents of this noncomparative format argue
that consumers do not have the contextual knowledge required to
critically evaluate comparative claims. Opponents contend that
consumers could evaluate comparative claims that are properly framed
and fairly balanced.
4. Help-Seeking
Help-seeking promotional materials encourage consumers with
particular symptoms, conditions, or diseases to consult their doctor to
discuss general treatment options, but do not mention specific
prescription drug products.
If the only available treatment for a condition is a specific
prescription drug product, help-seeking materials may not be employed.
In such a case, materials focusing on the condition would, by
implication, promote the product. In addition, help-seeking materials
may not include ``linkages,'' i.e., logos, tag lines, graphics, etc.,
to product-specific materials. Linkages create a clear association
between a disease and a prescription drug, resulting in the
interpretation of the help-seeking material as product-claim material.
Help-seeking materials that include linkages are regulated as product-
claim materials.
As direct-to-consumer promotion has become more sophisticated, some
opponents have questioned FDA's decision not to regulate help-seeking
materials. They argue that even in the absence of direct linkages, many
consumers are able to connect the sponsoring manufacturer with a
specific prescription drug.
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5. Reminder
Reminder promotional materials are a means of reinforcing name
recognition and brand loyalty. When targeted toward prescribers,
manufacturers anticipate that this marketing technique will increase
the frequency with which a prescriber recalls the name of a drug and
its clinical role. This process is expected to result in an increased
number of prescriptions for the manufacturer's product. The utility of
reminder materials for consumers has not been resolved. Consumers are
less likely to associate the brand name of a prescription drug with its
clinical function(s). Moreover, consumers generally do not make
prescribing decisions. Therefore, many question the value of this
marketing technique for consumers, which, by definition, fails to
provide clinical information.
6. Disclosure Requirements for Print Labeling and Advertising
As described previously, the act requires that non-reminder
labeling bear ``adequate directions for use'' of the product (21 U.S.C.
352(f)) and that non-reminder advertising include a ``true statement of
* * * other information in brief summary relating to side effects,
contraindications, and effectiveness'' (21 U.S.C. 352(n)). This
statement has become known as the ``brief summary.'' These disclosure
requirements are generally satisfied by reprinting the full package
insert with labeling or the brief summary with advertising. However,
the package insert is written in technical language intended for health
care professionals and is relatively inaccessible to consumers.
Consequently, the value of this information for consumers is
questionable. At issue is whether the same information could be
presented in a format and language more easily understood by consumers.
7. Disclosure Requirements for Broadcast Advertising
Broadcast advertisements (radio, television, or telephone
communications systems) must contain a brief summary, unless ``adequate
provision is made for dissemination'' of the approved labeling in
connection with the presentation (Sec. 202.1(e)(1)). Advertisements
targeted to health care professionals may meet this requirement by
providing the page number for the advertised product in the Physicians'
Desk Reference (PDR), along with a toll-free telephone number by which
the professional may request a copy of the package insert. Most
consumers do not have ready access to the PDR. Therefore, such a page
reference would be inadequate.
Because of the difficulty of satisfying the disclosure requirement,
consumer-directed broadcast advertisements have been largely limited to
reminder and help-seeking advertisements. Reminder and help-seeking
advertisements are exempt from the disclosure requirements. New methods
of satisfying the ``adequate provision'' requirement, such as scrolling
the approved product labeling following television broadcasts, continue
to be explored.
Broadcast advertisements also are required to present information
relating to the major risks (i.e., side effects, warnings, precautions,
and contraindications) of the drug (Sec. 202.1(e)(1)). This disclosure
is commonly referred to as the ``major statement.'' The major statement
must be presented as an integral part of the broadcast advertisement
and be communicated in language understood by consumers. Nevertheless,
the major statement is a relatively fleeting disclosure and many have
questioned the ability of the consumer to comprehend and process the
information.
8. Fair Balance
As discussed earlier, the regulations require that advertisements
present a fair balance of benefit and risk information. Claims of drug
benefits, such as safety and efficacy, must be balanced with relevant
disclosures of risks and limitations of efficacy. The regulations also
require that the risk information be presented with a prominence and
readability reasonably comparable to claims about drug benefits
(Sec. 202.1(e)(7)(viii)). In consumer-directed promotion, FDA has
interpreted these requirements to mean that balancing information
should appear in the body copy of the promotional material in language
understood by consumers. Balancing information is intended to provide a
framework for the consumer to understand and evaluate drug benefit
claims, allowing them to form accurate opinions about prescription
drugs. These disclosures, often referred to as ``critical messages,''
also serve to facilitate and focus the physician-patient interaction.
Opponents of direct-to-consumer promotion argue that critical
messages cannot provide consumers with the contextual knowledge
required to assess the risks associated with the use of a prescription
drug. Accordingly, they would like to see direct-to-consumer promotion
halted.
9. Consumer Services
Manufacturer-sponsored patient-support programs are becoming
increasingly common. These programs are highly visible to consumers and
may be perceived as adding value to their therapy. Such programs offer
services such as patient counseling, care giver counseling, therapy
compliance tracking, and disease monitoring. These programs may allow
the drug manufacturer to influence the course of drug therapy beyond
the initial prescribing decision. Disclosure of the manufacturer's
sponsorship is not always clear. For example, some of these services
may appear to be sponsored by the patient's physician or other health
care provider.
Other manufacturer-sponsored consumer services appear to be
sponsored by unbiased third parties, such as disease-specific
foundations. This relationship may be utilized in many ways. For
instance, the foundation may disseminate manufacturer-prepared drug
information to consumers on behalf of the manufacturer. Consumers may
not be aware of the true source of the information, and consequently,
they may not evaluate this information as critically as they would
manufacturer-disseminated information. At issue is whether or not these
services mislead consumers.
II. Scope of the Hearing
In light of the many complex public health issues raised by direct-
to-consumer prescription drug promotion, FDA is soliciting broad public
participation and comment concerning this area. FDA is particularly
interested in exploring whether, and, if so, how, the agency's current
regulatory approach should be modified. As direct-to-consumer promotion
evolves, FDA will continue to help ensure that consumers receive
timely, understandable, and accurate information about prescription
drugs.
Examples of issues that are of interest to the agency include the
following:
1. What is known about the effects of direct-to-consumer promotion?
What effects, if any, does direct-to-consumer promotion have on the
public health?
2. Does direct-to-consumer promotion oversimplify the safety and
effectiveness of prescription drugs? If so, what impact does such
oversimplification have on the public health?
3. Can consumers understand and accurately assess claims regarding
the efficacy and safety of prescription drugs? What kind of additional
information, if any, should be required
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in the presentation of comparative drug claims to ensure that consumers
understand and may critically evaluate them?
4. Reminder advertisements, by definition, lack contextual and risk
information. What role do such advertisements play in consumer
promotion? Are such advertisements useful for consumers?
5. (a) Current regulations require inclusion of a ``brief summary''
of prescribing information in print advertisements. Is this form of
disclosure effective for consumers? Is it informative? Should there be
alternate requirements for risk disclosure, and, if so, what should
they be? (b) Current regulations require that broadcast advertisements
present a ``brief summary'' of prescribing information unless adequate
provision is made for the dissemination of the approved product
labeling. Also required is a statement of the major risks of the
product. Are these disclosure requirements effective and informative
for consumers? Are there alternate types of risk disclosures that are
more effective or informative? If so, what are they?
6. New technologies have spurred the growth of computer-based
promotional vehicles, such as electronic bulletin boards, kiosks in
pharmacies, the Internet, etc. These promotions are neither purely
print nor broadcast. What disclosure requirements, in general, should
be used for such consumer-directed prescription drug promotion?
7. ``Infomercials'' are program-length television or radio programs
that promote prescription drugs to consumers. What restrictions and/or
disclosures should be required of infomercials promoting prescription
drugs to consumers?
8. To help ensure that advertisements will be in ``fair balance,''
FDA currently requests disclosure of key risk and/or limitations of
efficacy information, i.e., critical messages, in consumer-directed
prescription drug promotion. In general, are such disclosures effective
and informative for this audience? What kinds of information should be
disclosed?
9. Some manufacturer-supported direct-to-consumer promotion appears
to be sponsored by independent, third-party services, such as mailings
from disease-specific foundations or disease management support
services. What disclosures should be required to inform consumers of
the source of the communication?
III. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
presiding officer will be the Commissioner of Food and Drugs or his
designee. The presiding officer will be accompanied by a panel of
Public Health Service employees with relevant expertise.
Persons who wish to participate in the part 15 hearing must file a
written notice of participation with the Dockets Management Branch
(address above) by September 15, 1995. To ensure timely handling, the
outer envelope should be clearly marked with docket number 95N-0227 and
the statement ``Direct-to-Consumer Hearing.'' Groups should submit two
copies. The notice of participation should contain the person's name;
address; telephone number; affiliation, if any; brief summary of the
presentation; and approximate amount of time requested for the
presentation. The agency requests that interested persons and groups
having similar interests consolidate their comments and present them
through a single representative. FDA will allocate the time available
for the hearing among the persons who file notices of participation as
described above. If time permits, FDA may allow interested persons
attending the hearing who did not submit a written notice of
participation in advance to make an oral presentation at the conclusion
of the hearing.
After reviewing the notices of participation and accompanying
information, FDA will schedule each appearance and notify each
participant by telephone of the time allotted to the person and the
approximate time the person's presentation is scheduled to begin. The
hearing schedule will be available at the hearing. After the hearing,
the schedule will be placed on file in the Dockets Management Branch
under docket number 95N-0227.
Under Sec. 15.30(f), the hearing is informal and the rules of
evidence do not apply. The presiding officer and any panel members may
question any person during or at the conclusion of their presentation.
No other person attending the hearing may question a person making a
presentation or interrupt the presentation of a participant.
Public hearings under part 15 are subject to FDA's guideline (21
CFR part 10, subpart C) on the policy and procedures for electronic
media coverage of public administrative proceedings. Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as required by
Sec. 15.30(b). Orders for copies of the transcript can be placed at the
meeting or through the Dockets Management Branch (address above).
Any handicapped person requiring special accommodations in order
to attend the hearing should direct those needs to the contact person
listed above.
To the extent that the conditions for the hearing, as described in
this notice, conflict with any provisions set out in part 15, this
notice acts as a waiver of those provisions as specified in
Sec. 15.30(h).
To permit time for all interested persons to submit data,
information, or views on this subject, the administrative record of the
hearing will remain open following the hearing until December 29, 1995.
Dated: August 7, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-20314 Filed 8-15-95; 8:45 am]
BILLING CODE 4160-01-F