[Federal Register: August 12, 2003 (Volume 68, Number 155)]
[Notices]
[Page 47920-47923]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au03-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 2003N-0344]
Consumer-Directed Promotion; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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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.
SUPPLEMENTARY INFORMATION:
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''
requirement.
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
following:
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
information?
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
understanding?
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
product.
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
information:
[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
or
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]
BILLING CODE 4160-01-S