[Federal Register Volume 66, Number 53 (Monday, March 19, 2001)]
[Notices]
[Pages 15494-15495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0078]


Agency Information Collection Activities; Proposed Collections; 
Comment Request; Assessment of Physician and Patient Attitudes Toward 
Direct-to-Consumer Promotion of Prescription Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on two proposed collections of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on surveys of physicians and 
patients to examine the impact of direct-to-consumer (DTC) promotion of 
prescription drugs.

DATES: Submit written or electronic comments on the collections of 
information by May 18, 2001.

ADDRESSES: Submit electronic comments on the collections of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collections of information to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be 
identified with the docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques when appropriate, and other forms of 
information technology.

Assessment of Physician and Patient Attitudes Toward Direct-to-
Consumer Promotion of Prescription Drugs

    Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is 
responsible for ensuring that the labeling and advertising of 
prescription drugs is truthful and not misleading. Section 502(n) of 
the act (21 U.S.C. 352(n)) prohibits the advertising of prescription 
drugs that is false or misleading or that fails to provide required 
information about product risks. Although advertising of prescription 
drugs was once primarily addressed to health professionals, consumers 
increasingly have become a primary target audience, and DTC advertising 
has dramatically increased in the past few years. However, DTC 
advertising raises many questions and issues. While it may alert 
consumers to new information and facilitate treatment of their medical 
problems, it also may confuse consumers and adversely impact the 
relationship between patients and their health care providers. In 
August 1997, when the agency issued its draft guidance on consumer-
directed broadcast advertisements, FDA announced that it intended to 
evaluate the effects of the guidance and of DTC promotion in general 
within 2 years of finalizing the guidance. The guidance was finalized 
on August 9, 1999 (64 FR 43197). In the notice announcing

[[Page 15495]]

availability of the final guidance, FDA reiterated its intent to 
evaluate the effects of the guidance, including effects on the public 
health, within 2 years. As part of that evaluation, the agency 
conducted a baseline public information collection focused on recent 
patients, concerning the effects of DTC advertising on patient-doctor 
interactions and attitudes toward DTC advertising in appropriate, and 
other forms of information technology.
    The purpose of the proposed information collection is to follow up 
on the agency's 1999 patient survey and expand information collection 
to include physicians. FDA needs information from physicians and 
patients about their reactions to, and behaviors that stem from, DTC 
prescription drug advertising in order to develop policy on appropriate 
requirements for regulating drug product promotional materials.
    Two data collections will be conducted: A patient survey and a 
physician survey. The patient survey will be conducted through 
randomized telephone interviews with a national probability sample 
consisting of 775 adults 18 years of age and over who have recently 
visited a physician. The sample will be limited to those respondents 
who have seen a doctor or other health care professional in the last 3 
months. Patient respondents will be asked their views about any 
prescription drug they may have received and prescription drugs in 
general, and their attitudes and behavior in relation to DTC 
advertising. Demographic information will also be collected.
    The physician survey will be conducted through telephone interviews 
with a national probability sample of office-based physicians who 
engage in-patient care at least half of the time. The sampling frame of 
physicians will consist of names drawn from the American Medical 
Association's Physician Masterfile. In an effort to maximize the 
response rate for physicians, prenotification letters will be mailed to 
all potential physician respondents. The survey itself will cover DTC-
related patient interactions, perceived patient outcomes, attitudes 
toward appropriate DTC categories, and general opinions about DTC 
advertising. Demographic information will also be collected.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                             Annual Frequency       Total Annual
     No. of Respondents        per Response          Responses         Hours per Response        Total Hours
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11,625 (consumer screener)          1               11,625                      .017               197.6
775 (consumer survey)               1                  775                      .333               258.1
3,333 (physician screener)          1                3,333                      .017                56.7
500 (physician survey)              1                  500                      .250               125.0
Total                                                                                              637.4
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\1\ There are no capital costs or operating and maintenance costs associated with these collections of
  information.


    Dated: March 12, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-6690 Filed 3-16-01; 8:45 am]
BILLING CODE 4160-01-S