[Federal Register Volume 64, Number 152 (Monday, August 9, 1999)]
[Notices]
[Pages 43197-43198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20364]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0302]
Guidance For Industry on Consumer-Directed Broadcast
Advertisements; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a final
guidance for industry entitled ``Consumer-Directed Broadcast
Advertisements.'' The agency sought public comment on a draft version
of this guidance, which was announced in the Federal Register of August
12, 1997. The agency considered the comments received and, where
appropriate, revised the draft guidance. The final guidance describes
how consumer-directed broadcast advertisements for prescription drugs
for humans and animals, and human biological products, may comply with
the requirement that they make adequate provision for dissemination of
the approved package labeling.
DATES: Written comments on the final guidance may be submitted at any
time.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written requests for copies of the final
guidance to the Office of Training and Communications, Division of
Communications Management, Drug Information Branch (HFD-210), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, http://www.fda.gov/cder/guidance/
index.htm; or Office of Communication, Training,
[[Page 43198]]
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, http://www.fda.gov/cber/guidelines.htm, FAX
1-888-CBERFAX or 301-827-3844, Mail: the Voice Information System at
800-835-4709 or 301-827-1800; or Communications Staff (HFV-12), Center
for Veterinary Medicine (CVM), 7500 Standish Pl., Rockville, MD 20855,
301-594-1755, http://www.fda.gov/cvm.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription human drugs: Nancy M. Ostrove, Center for
Drug Evaluation and Research (HFD-40), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-2828, or via e-mail at
``[email protected]''.
Regarding prescription human biological products: Toni M. Stifano,
Center for Biologics Evaluation and Research (HFM-602), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3028, or via e-mail at ``[email protected]''.
Regarding prescription animal drugs: Mukund R. Parkhie, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6642, or via e-mail at
``[email protected]''.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 12, 1997
(62 FR 43171), FDA announced the availability of a draft guidance for
industry concerning consumer-directed broadcast advertisements. The
draft guidance was intended to describe how advertisers could fulfill
their obligations under the regulations to provide consumers with
necessary risk information in connection with prescription drug
advertisements broadcast through general public media such as radio,
television, and telephone communications systems. The prescription drug
advertising regulations (Sec. 202.1 (21 CFR 202.1)) distinguish between
print and broadcast advertisements. Print advertisements must include a
``brief summary,'' which generally contains each risk concept in the
product's approved package labeling. In contrast, advertisements
broadcast through media such as television, radio, or telephone
communications systems must disclose the product's major risks in
either the audio or audio and visual parts of the presentation; this is
sometimes called the ``major statement.'' Sponsors of broadcast
advertisements are also required to present a brief summary, or
alternatively, may make ``adequate provision * * * for dissemination of
the approved or permitted package labeling in connection with the
broadcast presentation'' (Sec. 202.1(e)(1)). The draft guidance
described and explained the rationale behind one possible multifaceted
approach that would fulfill the ``adequate provision'' requirement.
After considering comments received by the public, FDA has revised
the draft guidance and is publishing it as a final guidance. FDA notes
that although the comments did not address the specific issue of
telephone advertisements, the lack of a specific discussion concerning
such advertisements may have led to the assumption that the same
multifaceted approach appropriate for television and radio
advertisements was also appropriate for telephone advertisements.
Therefore, in the final guidance FDA clarified its position with regard
to fulfilling the ``adequate provision'' requirement for telephone
advertisements. Aside from the addition of this clarification and the
revision of introductory language to reinforce the importance in
broadcast advertisements of complying with the more general
requirements of the advertising regulations, there were no major
revisions to the draft guidance.
As specified in its good guidance practices policy (62 FR 8961,
February 27, 1997), the agency is not obliged to specifically address
every comment on a draft or final guidance. However, because this draft
guidance had a substantial impact on the direct-to-consumer broadcast
environment, FDA believes that discussion of the agency's response to
some of the issues raised in the comments will be helpful to certain
individuals and groups. Therefore, FDA has placed a document entitled
``Consumer-Directed Broadcast Advertisements Guidance: Questions and
Answers'' in the docket with this final guidance (see docket number in
brackets in the heading of this document), as well as on FDA's website
at ``www.fda.gov/cder/guidance/index.htm''.
As discussed in the August 12, 1997, Federal Register notice
announcing availability of the draft guidance, within 2 years of
publication of this final guidance, FDA intends to evaluate its effects
on the public health. At the end of this evaluation period, FDA will
determine whether this guidance should be withdrawn, continued, or
modified to reflect the agency's current thinking.
This guidance for industry represents the agency's current thinking
on consumer-directed broadcast advertisements. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute, regulations, or
both.
Interested persons may, at any time, submit written comments on the
final guidance to the Dockets Management Branch (address above). Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. The final guidance
and received comments are available for public examination in the
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: June 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-20364 Filed 8-6-99; 8:45 am]
BILLING CODE 4160-01-F