54054 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Financial Status Reporting Form for program of State Council on Developmental Disabilities ........................................................................................ 55 1 8 440 

Estimated Total Annual Burden 

Hours: 440. 

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

grjohnson@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 7, 2005. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 05–18045 Filed 9–12–05; 8:45 am] 

BILLING CODE 4184–01–M 

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. 

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://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:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/meetings/meetingdocket.cfm. 

Comments about the meeting or 

comments after the meeting should be 

submitted to http://www.fda.gov/ 

dockets/ecomments. Written or 

electronic comments can be submitted 

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://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://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 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 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 (§ 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’’ (§ 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 

§ 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 § 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://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://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://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 

54056 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 

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 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 consumerdirected 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://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://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://www.fda.gov/cder/guidance/ 

index.htm. 

The public comments on these draft 

guidances are available at http:// 

www.fda.gov/ohrms/dockets. 

• FDA conducted research to examine 

how DTC promotion affects the patientphysician 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:// 

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:// 

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 § 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 § 202.1. Finally, two 

petitions (Docket No. 1995P–0224/CP1 

& CP2) reference and reiterate requests 

of earlier petitions to stop regulating 

DTC advertising under § 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 physicianpatient 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. 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 54057 

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). 

2The 2004 final report on these surveys can be 

found at http://cdernet/ddmac/www-site/ 

researchka.htm. 

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 ads1 in all types of consumer 

promotion, such as broadcast, print, and 

the Internet? 

One important consideration in 

understanding how to use prescription 

drugs and medical devices is the riskbenefit 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. 

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 (§ 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 

(§ 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 moneyback 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. 

54058 Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 

• 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 (§ 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’’ (§ 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. 

Federal Register / Vol. 70, No. 176 / Tuesday, September 13, 2005 / Notices 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 consumerdirected 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 § 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 § 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 § 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 

§ 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://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 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[DHS–2005–0061] 

Data Privacy and Integrity Advisory 

Committee 

AGENCY: Office of the Secretary, 

Department of Homeland Security.