[Federal Register: September 13, 2005 (Volume 70, Number 176)]
[Page 54054-54059]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0354]

Consumer-Directed Promotion of Regulated Medical Products; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.


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 

    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: 

    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 


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 
    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 
    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 

     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 

    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 

     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 
    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?

    \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).

    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.

    \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


    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 
    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 
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 
    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 
    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.  
    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.  

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 

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]