[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 

[[Page 42582]]
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. 

[[Page 42583]]

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 

[[Page 42584]]
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