[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Notices]
[Pages 42664-42665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20363]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0078]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Assessment of Physician and Patient Attitudes 
Toward Direct-to-Consumer (DTC) Promotion Drugs; Survey

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
September 13, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Assessment of Physician and Patient Attitudes Toward Direct-to-
Consumer (DTC) Promotion Drugs; Survey

    Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is

[[Page 42665]]

responsible for assuring 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 ``direct-to-
consumer'' (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 would 
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 
Federal Register notice announcing 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 general (OMB Control No. 0910-0399). The purpose of the 
proposed information collection is to followup 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.
    The collection effort will consist of two separate parts: A patient 
survey and a physician survey. The patient survey will be conducted 
through national randomized telephone interviews with a national 
probability sample with 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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                                                             Total Annual
  No. of Respondents      Annual Frequency per Response        Responses     Hours per Response     Total Hours
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11,625 (consumer                                        1    11,625                   .017            197.6
 screener)
775 (consumer survey)                                   1       775                   .333            258.1
3,333 (physician                                        1     3,333                   .017             56.7
 screener)
500 (physician                                          1       500                   .250            125.0
 survey)
                                                                                                 ---------------
 Total                                                                                                637.4
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    In the Federal Register of March 19, 2001 (66 FR 15494), the agency 
requested comments on the proposed collections of information. Comments 
were received from 31 organizations and individuals. The comments were 
grouped according to similarity.
    1. Seven comments were unrelated to the proposed information 
collection.
    2. Sixteen comments addressed general aspects of the information 
collection. Of these, 12 comments were supportive of the information 
collection as proposed. Four comments recommended a focus on behaviors 
rather than attitudes. This included two comments, which suggested a 
case study design rather than a survey. We note that the proposed 
physician survey does ask the physician to focus on a specific event 
when answering questions about their interaction with a patient who had 
asked about a prescription drug, as well as any specific drugs that 
were discussed during the interaction. In addition, both the patient 
and physician surveys ask questions about the effect of DTC advertising 
on behaviors occurring during an office visit.
    3. Eight comments addressed specific aspects of the questionnaire, 
including wording, sample, and additional areas of inquiry. The 
questionnaires were extensively revised to reflect these comments.
    A pilot test of the questionnaires was conducted by the contractor 
to confirm estimates of timing, identify problems related to 
questionnaire wording and order of presentation, and ensure
that the questionnaire placed a minimal burden on respondents. The 
pretest included nine patient test respondents and nine physician test 
respondents. The pretest revealed that no substantive changes were 
necessary.

    Dated: August 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-20363 Filed 8-13-01; 8:45 am]
BILLING CODE 4160-01-S