[Federal Register: August 12, 2003 (Volume 68, Number 155)]
[Page 47920-47923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



[Docket No. 2003N-0344]

Consumer-Directed Promotion; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on consumer-directed promotion of prescription drugs. The 
purpose of the meeting is to enable the agency and other persons and 
organizations to present the results of their research on consumer-
directed promotion of prescription drug products through print, 
broadcast, and other types of media. FDA is particularly

[[Page 47921]]

interested in hearing about research by other persons and organizations 
that provides insight into the effects that consumer-directed promotion 
has on the public health. The agency is also interested in research on 
the groups most affected by consumer-directed promotion, including 
patients, caretakers, physicians, physician assistants, nurses, 
pharmacists, managed care organizations, and insurers.
    Date and Time: The public meeting will be held on September 22, 
2003, from 9 a.m. to 5 p.m., and on September 23, 2003, from 9 a.m. to 
5 p.m. Presenters must send final electronic presentations in Microsoft 
PowerPoint, Microsoft Word, or Adobe Portable Document Format (PDF) to 
FDA by close of business on September 10, 2003.
    Persons interested in presenting research should send requests and 
abstracts in writing to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville 
MD, 20852, by close of business on August 29, 2003.
    Location: The public hearing will be held at the National 
Transportation Safety Board Boardroom and Conference Center, 429 
L'Enfant Plaza, SW., Washington, DC 20594. (Phone: 202-314-6421; Metro: 
L'Enfant Plaza station on the green, yellow, blue, and orange lines). 
See: http://ntsb.gov/events/newlocation.htm. (FDA has verified the Web 
site address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)
    Registration and Requests for Presentation: No registration is 
required to attend the meeting. Seating will be on a first-come, first-
served basis. If you wish to present research during the public 
meeting, please submit your request and an abstract of your 
presentation to the Division of Dockets Management (see Date and Time). 
Requests should be identified with the docket number listed in the 
heading of this document. Transcripts of the meeting will be available 
for review at the Division of Dockets Management.
    For Information Regarding This Notice: Rose Cunningham, Center for 
Drug Evaluation and Research (HFD-006), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-594-5468, e-mail: 
cunninghamr@cder.fda.gov. If you need special accommodations due to a 
disability, please inform the contact person.


I. Background

    Part of FDA's Division of Drug Marketing, Advertising and 
Communication's (DDMAC) mission is to protect public health by helping 
to ensure that prescription drug promotion directed to professionals 
and consumers is truthful, contains balanced risk and benefit 
information, and is accurately communicated. Increased spending on 
consumer-directed (also called direct to consumer promotion or DTC 
promotion) promotion, particularly broadcast advertisements, has 
stimulated public debate about its value or harm to the public. 
Proponents argue that DTC promotion is of educational value, will 
improve the physician-patient relationship, will make consumers aware 
of conditions they have that could benefit from treatment, would 
potentially improve health care, and could lower long-term health care 
costs through early recognition and treatment. Opponents contend that: 
Consumers do not have the expertise to accurately evaluate and 
comprehend prescription drug advertising, DTC promotion is typically 
misleading because it fails to adequately communicate risk information, 
DTC promotion will damage the physician-patient relationship, it will 
increase drug prices, lead to over-medication and drug abuse, and it 
will lead to use of the most costly alternatives. FDA needs to consider 
all points of view in the public debate.
    In the Federal Register of August 12, 1997 (62 FR 43171), FDA 
announced the availability of a draft guidance for industry concerning 
DTC broadcast advertisements. The draft guidance was intended to 
describe how advertisers could fulfill their obligations under the 
regulations to provide consumers with necessary risk information in 
connection with prescription-drug advertisements broadcast, through 
general public media such as radio, television, and telephone 
communications systems. The prescription drug advertising regulations 
under part 202.1 (21 CFR 202.1) distinguish between print and broadcast 
advertisements. In addition to presenting a fair balance between 
information relating to side effects and contraindications and 
information relating to the effectiveness of the drug, print 
advertisements must include a ``brief summary,'' that generally 
includes all risks cited in the product's approved package labeling. In 
contrast, advertisements broadcast through media such as television, 
radio, or telephone communications systems must disclose the product's 
major risks in either the audio or audio and visual parts of the 
presentation (this is sometimes called the ``major statement''); but 
need not provide the brief summary, as this would generally be 
impractical in broadcast or telephone media. Instead these 
advertisements may make ``adequate provision * * * for dissemination of 
the approved or permitted package labeling in connection with the 
broadcast presentation'' (Sec.  202.1(e)(1)). The draft guidance 
described, and explained the rationale behind, one possible 
multifaceted approach that would fulfill the ``adequate provision'' 
    After considering comments received from the public, the agency 
revised the draft guidance and published it as a final guidance on 
August 9, 1999 (64 FR 43197). FDA noted that although the comments did 
not address the specific issue of telephone advertisements, the lack of 
a specific discussion concerning such advertisements may have led to 
the assumption that the same multifaceted approach for television and 
radio advertisements was also appropriate for telephone advertisements. 
Therefore, in the final guidance, FDA clarified its position with 
regard to fulfilling the ``adequate provision'' requirement for 
telephone advertisements. Aside from this clarification and the 
revision of introductory language to reinforce the importance in 
broadcast advertisements of complying with the more general 
requirements of the advertising regulations, there were no major 
revisions to the draft guidance. The final guidance and a document 
entitled ``Consumer-Directed Broadcast Advertisements Guidance: 
Questions and Answers'' is available on FDA's Web site at www.fda.gov/cder/guidance/index.htm
    The agency said in the August 9, 1999, Federal Register notice 
announcing availability of the final guidance, that the agency intended 
to evaluate the effects of the guidance and DTC promotion, in general, 
on the public health. FDA said it would determine whether this guidance 
should be withdrawn, continued, or modified to reflect the agency's 
current thinking. The public meeting being announced in this document 
is one component of the approach the agency is taking to fulfill its 
commitment to this evaluation.
    Another component is the research FDA has conducted on DTC 
promotion, including surveys of consumers in 1999 and 2002, as well as 
a survey of physicians in 2002 that explored how DTC promotion affects 
the patient-physician relationship. FDA intends to present the results 
of those findings at the public meeting.

[[Page 47922]]

II. Scope of the Meeting

    In light of the many complex public health issues raised by DTC 
prescription drug promotion, the agency stated, in previous Federal 
Register notices that it needed rigorous studies to assess the actual 
effects of DTC promotion and to help guide future policy. The agency is 
soliciting feedback on the results of such research for presentation at 
this public meeting. The meeting will give parties who have conducted 
rigorous research an opportunity to present their findings to FDA and 
the public. The agency will consider its own research and the research 
of others to explore whether, and, if so, how, the agency's current 
regulatory approach should be modified, including whether the guidance 
on DTC broadcast advertisements should be withdrawn, continued, or 
modified to reflect the agency's current thinking.
    FDA is interested in research related to the promotion and 
advertising of prescription drugs, both DTC advertising and the 
interaction of DTC and health care professional-oriented promotion. The 
research may be either broadly defined or specific, and narrowly 
focused, but it must meet accepted standards for rigorous research. 
Specific topics of interest include, but are not limited to, the 
    1. What is known about the effects of DTC promotion on patient and 
physician behavior, and what effects, if any, does DTC promotion have 
on public health? What measurements should be used as indicators of the 
influence of DTC promotion, and which are most important?
    2. Drugs ads used in DTC promotion include full-product 
advertisements, which include risk and benefit information, and shorter 
``reminder'' ads. These shorter advertisements do not provide 
contextual and risk information. In what ways do consumers differ in 
their processing of full product advertisements and drug promotions, 
such as reminder ads, that do not provide contextual and risk 
    3. Does DTC promotion oversimplify the safety and effectiveness of 
prescription drugs? If so, what effect does such oversimplification 
have on public health? Specifically, what effect does it have on 
consumer understanding of and use of prescription drugs?
    4. What impact does DTC promotion have on how patients interact 
with their health care professionals? Does this interaction affect 
health care providers' prescribing decisions?
    5. Can consumers understand and accurately assess claims regarding 
the efficacy of prescription drugs? Can consumers understand and 
accurately assess claims regarding the safety of prescription drugs? Do 
consumers understand the qualifiers in efficacy and safety claims that 
represent distinctions about the degree of scientific uncertainty and 
causality associated with a claim, such as ``may cause,'' ``risk 
factors include,'' ``individual results may vary,'' and other similar 
qualifiers? Given the fact that prescription drug use requires 
participation of a learned intermediary, how important is imperfect 
    6. What kind of additional information, if any, should be required 
in the presentation of comparative drug claims to help consumers 
understand and critically evaluate them? What kind of additional 
information, if any, should be required in the presentation of 
comparative cost claims? Should this information vary if prescription 
drugs are compared to other prescription drugs, over-the counter drugs, 
or other types of treatments?
    7. Current regulations require inclusion of a ``brief summary'' of 
prescribing information (side effects, contraindications, and 
effectiveness) in print advertisements. Does this form of disclosure 
effectively communicate to consumers? Is it informative? Should there 
be alternate requirements for risk disclosure, and, if so, what should 
they be? 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 would 
be more effective or informative? If so, what are the strengths and 
limitations of these alternative types of risk disclosures?
    8. The agency issued final guidance in 1999 on how pharmaceutical 
companies could meet the regulatory requirements to disseminate 
approved labeling for a prescription product in lieu of a scrolling 
``brief summary'' in broadcast advertisements. Are consumers making use 
of this method for obtaining brief summary information? What, if any, 
factors hinder effective use of this information, especially among 
consumer segments most needing it, such as those with limited knowledge 
of the brand and medical condition?
    9. New technologies have spurred the growth of computer-based 
promotional vehicles, such as the Internet, electronic bulletin boards, 
and kiosks in pharmacies. These promotions are neither purely print nor 
broadcast. What kind and format of information is necessary to ensure 
that these vehicles appropriately communicate risks and benefits of the 
    10. ''Infomercials'' are program-length television or radio 
programs that promote prescription drugs to consumers. How well do 
consumers understand the sponsorship of consumer-oriented 
``information'' promotions that differ in character from traditional 
promotion formats (15-, 30-, and 60-second ads)? How well do consumers 
understand the difference between benefit and risk claims based upon 
anecdotal evidence, such as a series of testimonials and product claims 
based upon scientific evidence?
    11. To help ensure that advertisements contain ``fair balance,'' 
FDA currently requests disclosure of key risk and/or limitations of 
efficacy information, i.e., critical messages, in DTC prescription drug 
promotion. In general, are such disclosures effective and informative 
for this audience? What kinds of information should be disclosed?
    12. Promotional materials that are disseminated directly by or on 
behalf of a pharmaceutical company (promotional labeling) are required 
to include the approved product labeling instead of a brief summary. 
How do consumers use product labeling, whether it is written for 
professionals or patients, and how does consumer use of labeling 
compare to consumer use of the brief summary?
    13. Some manufacturer-supported DTC promotion appears to be 
sponsored by independent, third-party services, such as mailings from, 
or Web sites posted by, disease-specific foundations or disease 
management support services. What kind of disclosures would help 
consumers understand the source of the communication?
    14. What additional research is needed to examine the effect of DTC 
advertising on public health and other DTC advertising issues? Is there 
research that the agency should conduct, and if so, what should be the 
focus of that research?
    FDA is planning this public meeting to present the findings of its 
surveys and to hear the results of DTC research conducted by 
individuals, associations, organizations, academia, and companies. The 
objective of the meeting is for FDA to gather information to help the 
agency explore whether, and, if so, how, the agency's current 
regulatory approach to DTC prescription drug promotion should be 
modified. The agency believes presentations of

[[Page 47923]]

research results will be the best format. Therefore, the 2-day meeting 
will be conducted as a series of presentations. First, FDA will present 
the findings of its surveys, then others who have been scheduled will 
present their findings. A panel of FDA officials will listen to each 
presenter and ask questions. The audience will then have an opportunity 
to ask questions and provide comments on the research.
    To ensure timely handling, the outer envelope should be clearly 
marked with the docket number listed in the heading in this document, 
along with the statement ``DTC Meeting.'' Groups should submit two 
copies. The request to participate should contain the following 
    [sbull] Presenter's name;
    [sbull] Address;
    [sbull] Telephone number;
    [sbull] E-mail address;
    [sbull] Affiliation, if any;
    [sbull] Abstract of the presentation;
    [sbull] Approximate amount of time requested for the presentation.
    The agency requests that persons who have collaborated on relevant 
research coordinate their comments and present them through a single 
representative. FDA will allocate the time available for the meeting 
among the persons who request to present research as described in this 
section II. Due to limited time, the agency will accept only one 
presenter from each company or organization. FDA reserves the right to 
turn down requests if the proposal is not research on an appropriate 
topic or is primarily qualitative. After reviewing the requests to 
present and the abstracts, the agency will schedule each appearance and 
notify each participant by e-mail or telephone of the time allotted to 
the person and the approximate time the person's presentation is 
scheduled to begin. Presenters must send final electronic presentations 
in Microsoft PowerPoint, Microsoft Word, or PDF to FDA by close of 
business on September 10, 2003. Failure to meet the deadline will 
result in the presenter forfeiting his or her presentation slot.
    The meeting schedule will be available both on the Internet at 
http://www.fda.gov/cder/ddmac/DTCmeeting2003.html and at the meeting. 
After the meeting, the schedule and presentations will be placed on 
file in the Division of Dockets Management under the docket number 
listed in the heading in the this document.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, written or electronic comments on or before 
December 1, 2003. You must submit two copies of comments, identified 
with the docket number found in brackets in the heading of this 
document. Submit electronic comments by December 1, 2003, to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm
fdadockets@oc.fda.gov. You should annotate and organize your comments 
to identify the specific questions to which they refer. Comments to the 
docket can be reviewed in the Division of Dockets Management, Monday 
through Friday between 9 a.m. and 4 p.m.

IV. Transcripts

    You can request a copy of the transcript of the meeting in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 30 working days after the meeting, at a cost of 10 cents 
per page or on a compact disk at a cost of $14.25 each. You can also 
examine the transcript Monday through Friday between 9 a.m. and 4 p.m. 
in the Division of Dockets Management.

    Dated: August 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-20522 Filed 8-7-03; 8:45 am]