[Federal Register: September 13, 2005 (Volume 70, Number 176)]
[Notices]
[Page 54054-54059]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13se05-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0354]
Consumer-Directed Promotion of Regulated Medical Products; 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 on direct-to-consumer (DTC) promotion of regulated medical
products, including prescription drugs for humans and animals,
vaccines, blood products, and medical devices. FDA is particularly
interested in hearing the views of individuals and groups most affected
by DTC promotion, including consumers, patients, caregivers, health
professionals (physicians, physicians' assistants, dentists, nurses,
pharmacists, veterinarians, and veterinarian technicians) managed care
organizations, and insurers, as well as the regulated industry. FDA is
seeking input on a number of specific questions, but is interested in
any other pertinent information participants in the hearing would like
to share.
Dates and Times: The public hearing will be held on November 1 and
2, 2005, from 9 a.m. to 5 p.m. Submit written or electronic notices of
participation by close of business on October 11, 2005. Written and
electronic comments will be accepted until February 28, 2006.
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, 202-314-6421; Metro:
L'Enfant Plaza station on the green, yellow, blue, and orange lines;
see: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://ntsb.gov/events/newlocation.htm. (FDA has verified the Web
site address, but FDA is not responsible for any changes to the Web
site after this document publishes in the Federal Register.)
Addresses: Written or electronic notices of participation should be
submitted to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
or on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
Comments about the meeting or comments
after the meeting should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments Written or electronic comments can be submitted to http://.
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/dockets/ecomments. A consolidated list of all documents
and other information related to the public hearing, such as the
Federal Register notice, the agenda, public comments, and transcripts
will be posted with their links, as the documents are made available,
on the Center for Drug Evaluation and Research (CDER) Web site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ddmac.
For further information contact: Rose Cunningham, Center for Drug
Evaluation and Research (HFD-006), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20852, 301-443-5595, e-mail:
cunninghmar@cder.fda.gov.
For registration to attend and/or to participate in the meeting:
Seating at the hearing is limited. People interested in attending the
meeting should register at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdocket.cfm.
Registration is free and will be
accepted on a first-come, first-served basis.
The procedures governing the hearing are found in part 15 (21 CFR
part 15). Anyone wishing to make an oral presentation during the
hearing must state this intention on the registration form (see
Addresses). To participate, submit your name, title, business
affiliation, address, telephone and fax numbers, and e-mail address.
A written statement also should be submitted at the time of
registration for each discussion question to be addressed, with the
names and addresses of all individuals who plan to participate, and the
approximate 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.
Individuals who have registered to make an oral presentation will be
notified of the scheduled time for their presentation prior to the
hearing. Depending on the number of presentations, FDA may need to
limit the time allotted for each presentation. FDA has identified
questions and subject matter of special interest in section III of this
document, but presentations do not have to be limited to those
questions. Presenters should
[[Page 54055]]
submit to the agency two copies of each presentation given. All
participants are encouraged to attend the entire 2-day meeting.
If special accommodations are needed because of a disability, the
registration contact person should be informed at the time of
registration.
SUPPLEMENTARY INFORMATION:
I. Background
A. Definition of Terms and Regulatory Requirements
Under the Federal Food, Drug, and Cosmetic Act (the act), FDA has
responsibility for regulating the labeling and advertising of
prescription drugs and medical devices. If an activity or material is
considered to be either advertising or labeling, it must meet certain
requirements. The regulatory framework for prescription drug labeling
and advertising is both more straightforward and more developed than is
the regulatory framework for the labeling and advertising of medical
devices.
Under section 201(m) of the act (21 U.S.C. 321(m)), labeling is
defined as including ``all labels and other written, printed, or
graphic'' materials ``upon'' or ``accompanying'' a regulated product.
The term ``accompanying'' has been broadly defined by the Supreme Court
(Kordel v. United States, 335 U.S. 345, 349-350 (1948)). FDA's
regulations give examples of labeling materials, including brochures,
mailing pieces, detailing pieces, calendars, price lists, letters,
motion picture films, and sound recordings (Sec. 202.1 (21 CFR
202.1(1)(2))).
FDA regulates the labeling of all drugs and devices under its
jurisdiction. Labeling must be truthful and nonmisleading (section
502(a) of the act (21 U.S.C. 352(a)). For human and veterinary
prescription drugs, 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) and 201.105(d)). This requirement is generally fulfilled
by including the full approved labeling for the product (the ``package
insert'') with the promotional materials. For devices, the requirement
of 21 U.S.C. 352(f) applies as well, and a device is misbranded unless
its labeling bears adequate instructions for use. A device that is safe
only if used under the supervision of a licensed practitioner and for
which adequate instructions for use can therefore not be provided, is
exempt from this requirement if, among other things, all of its
labeling that purports to furnish information on the use of the device
also contains adequate information for such use, including indications,
effects, routes, methods, and frequency and duration of administration
and any relevant hazards, contraindications, side effects, and
precautions, under which licensed practitioners can safely use the
device for the purposes for which it is intended.
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 issued by, or on behalf of, a
manufacturer, packer, or distributor and is intended to promote 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)).
The act specifies that, in addition to the identity of the product
and its quantitative composition, prescription drug 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 frequently is 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 considered 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 section 201(a) of
the act (21 U.S.C. 321(n)), and Sec. 202.1(e)).
FDA similarly regulates advertising for restricted devices. A
``restricted device'' is a device that may be restricted to the sale,
distribution, or use only with the written or oral authorization of a
licensed practitioner, or in accordance with other conditions if FDA
determines that there cannot otherwise be reasonable assurance of its
safety and effectiveness (section 502(e) of the act) 21 U.S.C.
360j(e)). Currently, three devices are restricted by regulation. FDA
also restricts devices through the approval orders granted to many
class III devices (21 U.S.C. 360e(d)(1)(B)(ii)).
According to the act, a restricted device is misbranded if its
advertising is false or misleading in any particular (21 U.S.C.
352(q)), or if its advertising does not contain a brief statement of
the intended uses of the device and relevant warnings, precautions,
side effects and contraindications (21 U.S.C. 352(r)). There are
currently no regulations establishing specific requirements for the
content or format of the advertisements for restricted devices.
B. History of DTC Promotion
A summary of milestones in the history of DTC promotion, with
embedded links to Web sites for additional background information, is
given in this section of the document. A consolidated list of these
documents and their links is available on the CDER Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ddmac
.
In response to early instances of DTC promotion, FDA
requested a voluntary moratorium on DTC promotion in a September 2,
1983, policy statement. During the moratorium, FDA sponsored a series
of public meetings and conducted research.
In the Federal Register of September 9, 1985 (56 FR
36677), the moratorium was withdrawn in a notice that stated that the
current regulations governing prescription drug advertising provide
``sufficient safeguards to protect consumers.''
In a July 1993 letter to the pharmaceutical industry, the
agency asked drug manufacturers to voluntarily submit proposed DTC
promotional material prior to use, allowing FDA the opportunity to
review and comment upon proposed materials before they reach consumers.
In the Federal Register of August 16, 1995 (60 FR 42581),
FDA announced a part 15 hearing to be held on October 18 and 19, 1995.
The agency solicited oral testimony and written responses to a series
of questions concerning DTC promotion of prescription drugs. The
transcripts of the public meeting are available on the CDER Web site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ddmac/meetings.htm.
In the Federal Register of May 14, 1996 (61 FR 24314), FDA
published a notice making it clear that FDA has never required
preclearance of consumer-directed prescription product promotion prior
to use and also soliciting additional information to help in the
development of overall policy related to consumer-directed promotion of
prescription products and restricted devices. This notice is available
on the CDER Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ddmac.
In the Federal Register of August 12, 1997 (62 FR 43171),
FDA announced the availability of a draft guidance for industry
describing ways in which consumer-directed broadcast
[[Page 54056]]
advertisements could make ``adequate provision'' for the dissemination
of the approved or permitted labeling in connection with the broadcast
ad. FDA revised the draft guidance and published it as a final guidance
on August 9, 1999 (64 FR 43197). The guidance and a document entitled
``Consumer-Directed Broadcast Advertisements Guidance: Questions and
Answers'' is available on CDER's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm
.
In February 2004, FDA published a notice of availability
and requested public comment on three draft guidances pertaining to
consumer-directed promotion of medical products. Comments on these
draft guidances are under consideration:
1. ``Consumer-Directed Broadcast Advertising of Restricted
Devices'' available on the Center for Devices and Radiological Health
(CDRH) Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/comp/guidance/1513.pdf.
2. ``Brief Summary: Disclosing Risk Information in Consumer-
Directed Print Advertisements'' available on the CDER Web site at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
3. ```Help-Seeking' and Other Disease Awareness Communications by
or on Behalf of Drug and Device Firms'' available on the CDER Web site
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm.
The public comments on these draft guidances are available at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
FDA conducted research to examine how DTC promotion
affects the patient-physician relationship. On September 22 and 23,
2003, FDA held a public meeting at which the agency and other persons
and organizations presented the results of their research on DTC
promotion of prescription drugs through print, broadcast, and other
types of media. The agenda, presentations, and transcripts from the
public meeting are posted on the CDER Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ddmac/DTCmeeting2003.html
.
On November 19, 2004, FDA published the results of its
research in a report entitled ``Patient and Physician Attitudes and
Behaviors Associated with DTC Promotion of Prescription Drugs--Summary
of FDA Survey Research Results.'' The final report is posted on the
CDER Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/ddmac/researchka.htm.
Medical device DTC promotion has not received as much FDA attention
because, until recently, there had not been a significant amount of DTC
device promotion except in limited areas. To date, FDA has not
conducted research specifically on the effects of DTC device promotion.
Because of recent increases in DTC device promotion and a growing
awareness among consumers that medical devices may give them important
choices, FDA wants to use this public hearing as a forum for those
interested in, and affected by, DTC promotion of medical devices.
C. Implementation of Current Regulations
There are no regulations that specifically address consumer-
directed promotional materials. Therefore, since 1985 FDA has applied
the act and the prescription drug advertising regulations to both
professional and consumer-directed promotion. Nor does the act
distinguish between consumer and professional audiences in its
requirement for disclosure of relevant risk information in prescription
drug or restricted device advertising. Nonetheless, FDA recognizes and
accounts for the differences between healthcare professionals and
consumers as recipients of drug promotion, including differences in
medical and pharmaceutical expertise, perception of pharmaceutical
claims, and information processing. For these reasons, in its
regulation of DTC promotion, FDA has tried to ensure that adequate
contextual information for benefits and risks is presented and to
encourage sponsors to provide such information in language
understandable to consumers.
D. Pending Citizen Petitions
We note that FDA has received a number of citizen petitions that
address DTC promotion. The positions advocated by these petitions vary
considerably. One petition (Docket No. 1991P-0337) requests that FDA
ban direct-to-consumer advertising of prescription drugs. A second
petition (Docket No. 1991P-0227) 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 (Docket Nos. 1989P-0505 and 1995P-0104), updated and reissued
by the petitioner, maintains that consumer-directed prescription drug
advertising should not be regulated under Sec. 202.1. It also
maintains: (1) That FDA should issue new regulations to address
prescription drug advertisements directed to consumers and (2) that
until such time as new regulations are established, FDA should issue a
policy statement and regulation stating that prescription drug
advertisements directed to the general public are exempt from the
advertising regulations under Sec. 202.1. Finally, two petitions
(Docket No. 1995P-0224/CP1 & CP2) reference and reiterate requests of
earlier petitions to stop regulating DTC advertising under Sec. 202.1
and also maintain that such regulations violate the First Amendment.
Consistent with 21 CFR 10.30(h)(2), FDA intends to use this public
hearing to further explore the issues raised in these citizen petitions
and hereby incorporates the records in these citizen petition dockets
into this docket.
II. Purpose and Scope of the Hearing
This hearing is intended to provide an opportunity for broad public
participation and comment concerning consumer-directed promotion of
regulated medical products, including human and animal prescription
drugs, vaccines, blood products, and medical devices. FDA is
particularly interested in hearing the views and comments from the
public as to whether, and if so how, the agency's current regulations
and the agency's interpretation of those regulations and actions under
them should be modified to better address consumer-directed promotion
of regulated products. FDA is holding this hearing because it believes
the agency, the industry, and other members of the public now have
enough experience with DTC promotion to understand what regulatory
issues may need to be addressed in new FDA activities.
III. Issues for Discussion
Part of FDA's mission is to protect public health by helping to
ensure that the promotion of medical products directed to professionals
and consumers is truthful, not misleading, and contains balanced risk
and benefit information. The effects of DTC promotion have been widely
discussed. Proponents of DTC promotion argue that it has educational
value and will improve the physician-patient relationship, increase
patient compliance with drug therapy and physician visits, and
generally satisfy consumer interest in obtaining desired drug
information. Opponents contend that consumers do not have the expertise
to accurately evaluate and comprehend prescription drug advertising;
that physicians will feel pressure to prescribe drugs that are not
needed; and that DTC promotion will damage the physician-patient
relationship and increase drug prices.
The agency invites comment at the public hearing on the general
concept of DTC promotion and its role and consequences, positive or
negative; on the topics outlined in the following paragraphs; and on
any aspect of DTC that is of interest to a presenter.
[[Page 54057]]
1. Does current DTC promotion present the benefits and risks of using
medical products in an accurate, nonmisleading, balanced, and
understandable way?
Presentation of information on benefits and the limitations of
benefits
A drug or device's approved use, or indication, is a critical piece
of information for a person deciding whether to take a drug product or
use a medical device. Products often have important limitations to
their use, and these too need to be understood by a potential user.
Some products, for example, work only in certain populations, or work
with limited success; some products work only in combination with other
products, or should only be used if other treatments have failed. FDA
is interested in hearing whether the indications of a drug or device
can be effectively communicated to a lay audience under the confines of
DTC promotion and, in particular, whether the limitations of benefit
can be properly communicated. FDA is also specifically interested in
whether paying greater attention to the educational component of an
advertisement (i.e., devoting more attention to defining the disease
and its manifestations) would help consumers better understand the role
drug and device therapy may play in treating that disease. More
broadly, do DTC promotional ads directed at the nonmedical community
need additional educational content about the disease or condition?
What is the potential role of reminder ads\1\ in all types of consumer
promotion, such as broadcast, print, and the Internet?
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\1\``Reminder ads'' and ``reminder labeling'' contain the name
of the drug and other limited information, but exclude all
representations or suggestions about the drug(s). See 21 CFR
201.100(f), 202.1(e)(2)(i), and 801.109(d).
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One important consideration in understanding how to use
prescription drugs and medical devices is the risk-benefit tradeoff.
Research conducted by FDA and reported on in 2004 on patient and
physician views of DTC prescription drug promotion has shown that
patients and physicians believe that DTC promotion overemphasizes the
benefits of prescription drugs relative to risk information. Moreover,
although almost 80 percent of physicians thought that patients
understood the benefits of the drug, only 30 percent of physicians
believed that patients adequately understood the limitations of drug
efficacy. In addition, about 60 percent of patients believed that DTC
ads portray the drug as better than it really is, and about 40 percent
of patients thought that the ads make it seem like the drug will work
for everyone. In the 2002 patient survey, FDA found that 60 percent of
patients believed that DTC ads do not provide enough risk information
and, in the 2002 physician survey, 60 percent of physicians thought
that patients did not understand the risks and possible negative
effects of the advertised drug.\2\ Despite these negative views of the
adequacy of risk information, we know that risk information, as
required by the regulations, is present in all compliant full-product
advertisements. The agency is interested in hearing why consumers and
healthcare providers may believe that risk information is not being
communicated as clearly as benefit information, even though that
information is present. FDA has not conducted comparable research in
the area of device promotion, but part of the purpose of this meeting
is to answer questions applicable to devices as well as to drugs.
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\2\The 2004 final report on these surveys can be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://cdernet/ddmac/www-site/researchka.htm
.
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Consumer audiences include a wide range of specific audiences, such
as patients with fatal illnesses, the elderly or children, or
caregivers. Although some DTC promotion, such as television ads, is
directed to a broad audience, DTC promotion can also be targeted to a
specific population. One example of such promotion is a product
brochure that a healthcare professional gives to a patient along with a
prescription for the product. Some consumer audiences may be more
susceptible to being misled by false or misleading promotion. Should
the agency take the population targeted by DTC promotion into account
as it considers the regulatory framework for DTC promotion? If so, what
are the additional issues that FDA should consider with respect to DTC
promotion that reaches or targets specific consumer populations?
Presentation of risk information
The prescription drug regulations require that advertisements
present a fair balance of benefit and risk information (Sec.
202.1(e)(5)(ii)). They also specify that risk information be presented
with a prominence and readability reasonably comparable to claims about
drug benefits (Sec. 202.1(e)(7)(viii)). Although there are no specific
regulations addressing the ``fair balance'' of device promotion, the
requirements in the statute and the regulations for a ``brief
statement'' of intended use and relevant risk information reflect the
same concepts as those inherent in the fair balance requirement. In DTC
promotion, FDA has interpreted these requirements to mean that a
balanced discussion of the risks and benefits should appear in the body
of the promotional material, and FDA has encouraged sponsors to provide
such information in language understandable by consumers. Balancing
information is intended to provide a framework for the consumer to
understand and evaluate drug benefit claims in an informed manner.
These disclosures also serve to facilitate and focus the physician-
patient interaction. How could the content and format of risk
information in promotional pieces be better communicated to consumers?
Because consumers sometimes lack advanced medical knowledge, how can
FDA help ensure that those consumers who are not medical experts
understand a product's risks?
The specific forms of presentation in DTC prescription drug ads,
particularly in television broadcast ads, may affect consumers'
understanding of a product's risks. For example, the ad may continue to
present positive scenes of individuals enjoying the benefits of the
advertised product during the presentation of risk information, which
is usually presented separately from the benefit information. Do such
common advertising techniques create barriers to consumers'
understanding of risk information?
Use of certain standard advertising strategies
Advertising strategies typically used in nonmedical settings have
raised concern when such strategies are applied to prescription drugs
or restricted devices. For example, some companies offer consumers
coupons, free samples, free trials, and money-back guarantees for
prescription drugs in both full-product as well as reminder
advertisements (which do not inform the consumer about the benefits or
risks associated with the product). Are these approaches appropriate
ways to influence consumers?
Another standard marketing technique uses real people, or actors
portrayed as real people, to provide positive reports (testimonials)
about an advertised product. Applied to medical products, this
technique portrays patients who describe how a drug or device helped
them manage their medical condition. In rarer instances, healthcare
providers, or actors portraying them, vouch for the use of the product.
Such approaches plainly do not reflect a data-oriented approach to
promotion and may not be recognized by consumers as anecdotes. FDA is
interested in whether and how techniques mislead consumers about the
risk-benefit tradeoffs of prescription or restricted medical products.
[[Page 54058]]
Use of comparative DTC promotion
Promotion that compares one product to another or to several others
is becoming more common in DTC promotion. Given that this information
is often scientific or numerical in nature, how can companies convey
this information in a way that is informative to consumers without
advanced education, and how well are companies currently doing this?
One possibility is that for such promotion to be considered not
misleading, it would need to provide greater than usual contextual
information about how efficacy is measured; what the side effects of
the various drugs, drug classes, and devices are; and whether any
advantages of a drug or a device are accompanied by disadvantages.
2. Could changes in certain required prescription drug disclosures--the
package insert for print ``promotional'' labeling and the brief summary
for print advertisements--improve the usefulness of this information
for consumers?
For prescription drugs, the act requires that labeling bear
``adequate directions for use'' of the product (21 U.S.C. 352(f)). As
previously described in this document, this requirement is generally
satisfied by including the entire package insert (approved product
labeling) with a promotional labeling piece. However, as the package
insert is written in technical language intended for healthcare
professionals, its value for consumers is questionable. For promotional
labeling, is the current package insert the best way to meet the
requirement to bear adequate directions for use in consumer-directed
materials? Are there ways to modify the content, format, and language
of the package insert that would make this information more easily
understood by consumers?
Advertisements that make claims about the product must 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 is known as the ``brief summary.'' This
requirement is generally satisfied by reprinting the relevant sections
of the package insert as the brief summary and, for this reason, its
value for consumers is also questionable. As discussed in section II of
this document, FDA has issued a draft guidance entitled ``Brief
Summary: Disclosing Risk Information in Consumer-Directed Print
Advertisements.'' The draft guidance gives several recommended
alternatives to reprinting parts of the package insert as the brief
summary for DTC prescription drug print advertisements. FDA is
considering the comments that have been submitted to the Docket, but is
interested in any additional comments on these brief summary
recommendations and on other brief summary alternatives that would make
the required disclosure more understandable to consumers.
FDA is currently conducting research on the content and format of
the brief summary in DTC print ads for prescription drugs and will make
these results available when the research is completed.
3. Could changes in the requirements for disclosure of certain
information in broadcast advertising improve the usefulness of this
information for consumers?
Advertisements broadcast through media such as television, radio,
or telephone communications systems must disclose the product's major
risks (i.e., side effects, warnings, precautions, and
contraindications) in either the audio or audio and visual parts of the
presentation (Sec. 202.1(e)(1)). This is commonly referred to as the
``major statement.'' The major statement must convey the product's most
important risk information and be presented as an integral part of the
broadcast advertisement. It is typically presented in language that
consumers can understand. Nevertheless, the major statement is a
relatively brief disclosure, and many have questioned the ability of
consumers to comprehend and process the information.
Broadcast advertisements are, in addition, required to present a
brief summary or, alternatively, make ``adequate provision * * * for
dissemination of the approved or permitted package labeling in
connection with the broadcast presentation'' (Sec. 202.1(e)(1)). The
latter is referred to as the ``adequate provision'' requirement. FDA's
guidance ``Consumer-Directed Broadcast Advertisements'' describes an
approach that FDA believes fulfills the adequate provision requirement
for broadcast advertisements. Are there alternatives that would improve
how adequate provision is made for dissemination of labeling to
consumers?
The major statement, together with adequate provision for
dissemination of the product's approved labeling, provides the
information disclosure required for broadcast advertisements.
Is there a way to improve the usefulness of this critical
information?
4. Is there a way to make information in DTC promotion of medical
devices more useful to consumers?
Many of the act's requirements apply to both drug and device
promotion. Hence, many of the principles used to regulate prescription
drug advertising also apply to device advertising. Nevertheless, there
are no regulations pertaining to restricted device advertising. FDA is
committed to ensuring that consumers have accurate and nonmisleading
information concerning restricted medical devices.
The act does not distinguish between broadcast and print
advertising formats in its requirement for a brief statement of a
restricted device's intended use and relevant risk information. There
are no regulations that provide specific requirements or interpretation
of the statutory requirement regarding advertising of restricted
devices. Part of the agency's purpose in holding this hearing is to
gather information on whether regulations governing restricted device
advertising are necessary and, if so, what aspects of advertising
should be addressed.
5. As new communication technologies emerge, they create opportunities
for novel approaches to DTC promotion. What issues should the agency
consider with regard to the effect of these technologies on DTC
promotion?
The current regulations were written at a time when promotion was
directed toward physicians and most promotional pieces were static
print displays. Not only has the target for these promotions
broadened--most notably to include consumers--but the modes of
dissemination have changed and continue to evolve. For several years
now, DTC promotion has occurred on television and on the radio; both
vehicles are quite different from standard print media. In addition,
FDA research has shown great increases in the number of people who now
use the Internet to search for information about prescription drugs.
Drug companies produce video news releases, audio news releases, and
print ``advertorials,'' which are disseminated to TV and radio
stations. At times, TV and radio stations do not make it clear to
consumers that such promotional pieces are generated by regulated
industry. The agency is interested in hearing the public's views on
these promotional techniques and the issues they raise.
[[Page 54059]]
6. What action should FDA take when companies disseminate violative
promotional material to consumers?
For most prescription drugs and all devices, there is no
requirement that companies submit their promotional materials to FDA
before using them, and the U.S. Constitution limits the agency's
ability to preclear promotional materials. Rather, companies must
submit prescription drug promotional pieces at the time of their
initial use in public. Device promotional pieces are not subject to a
submission requirement. Under section 502(n) of the act, FDA can
require that sponsors obtain preapproval of prescription drug
advertisements only in ``extraordinary circumstances.'' As a result,
FDA's review of promotional materials is almost wholly post hoc, (i.e.,
after the materials have already appeared in public). Consequently, any
enforcement action that FDA takes will also be post hoc.
Most of FDA's enforcement actions ask sponsors to stop using the
violative materials. In some cases, for both professional- and
consumer-directed pieces, FDA also asks sponsors to run corrective
advertisements or issue corrective promotional materials to remedy
misimpressions created by false or misleading materials. The agency is
interested in hearing views on this type of enforcement approach for
consumer-directed promotional materials as well as other enforcement
approaches that might protect the public health.
IV. Notice of Hearing Under Part 15
The Commissioner of Food and Drugs (the Commissioner) is announcing
that the public hearing will be held in accordance with part 15. The
Commissioner will designate a presiding officer, who will be
accompanied by senior management from the Office of the Commissioner,
the Center for Biologics Evaluation and Research, CDER, CDRH, and the
Center for Veterinary Medicine.
Persons who wish to make an oral presentation during the part 15
hearing must file a written or electronic notice of participation with
the Division of Dockets Management (see Addresses). To ensure timely
handling, any outer envelope or subject heading should be clearly
marked with the docket number found in brackets in the heading of this
document along with the statement ``Consumer-Directed Promotion of
Medical Products.'' Groups should submit two written copies. The notice
of participation should contain the person's name; address; telephone
number; affiliation, if any; the sponsor of the presentation (e.g., the
organization paying travel expenses or fees), if any; a brief summary
of the presentation (including the specific discussion questions that
will be addressed); 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. 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 oral
presentation is scheduled to begin. FDA asks that participants set
aside both days of the meeting so that the agency can group
presentations on similar topics. The agency will let the participants
know as soon as possible the time and date the participant is scheduled
to present. FDA may also ask participants to rank order presentation
topics, and FDA may need to restrict the time allotted to each
participant. If time permits, FDA may allow interested persons
attending the hearing who did not submit a written or electronic notice
of participation in advance to make an oral presentation at the
conclusion of the hearing. The hearing schedule will be available at
the hearing. After the hearing, the hearing schedule will be placed on
file in the Division of Dockets Management under the docket number
found in brackets in the heading of this document.
Because of limited seating at the conference facility, FDA requests
that organizations restrict their number of attendees at the meeting to
five.
Under Sec. 15.30, the hearing is informal, and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10, subpart C (21 CFR part 10, subpart C)). 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 stipulated in Sec.
15.30(b).
Any handicapped persons requiring special accommodations to attend
the hearing should direct those needs to the contact person (see For
further information contact).
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).
V. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see Addresses) written or electronic notices of participation and
comments for consideration at the hearing. 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. Persons who wish to provide additional materials
for consideration should file these materials with the Division of
Dockets Management. You should annotate and organize your comments to
identify the specific questions to which they refer (see section III of
this document). Two copies of any mailed comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number at the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday. Transcripts of the
hearing also will be available for review at the Division of Dockets
Management.
VI. Transcripts
The transcript of the hearing will be available 30 days after the
hearing on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets, and orders
for copies of the transcript can be placed at the meeting or through
the Freedom of Information Staff (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857.
Dated: September 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18040 Filed 9-9-05; 8:52 am]
BILLING CODE 4160-01-S