[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appropriate, revised the draft guidance.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