E-DRUG: U.S. FDA's guidance for DTC prescription drug promotion
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Dear E-druggers,
Today, the U.S. Food and Drug Administration proposed new guidance
for prescription drug advertising to consumers. The press release
follows. Thanks
Syed Rizwanuddin Ahmad
E-drug moderator
Email: srahmad@essential.org
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P97-26 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Bradford Stone: (301)443-3285
August 8, 1997 Broadcast Media: (301)827-3434
Consumer Hotline: (800)532-4440
FDA TO REVIEW STANDARDS FOR ALL DIRECT-TO-CONSUMER (DTC)
RX DRUG PROMOTION
New Guidance for Prescription Drug TV and Radio Ads First Step
The Food and Drug Administration today issued a proposed
guidance that will clarify the requirements for prescription drug
advertisements for television and radio, and should result in
making the advertisements more understandable to consumers.
As the first step in a comprehensive review of all policies
on direct-to-consumer promotion for prescription medicines,
today's notice lays out a framework for TV and radio ads
promoting prescription drugs. The ads will be required to
include information about any major risks, as well as
instructions for how consumers can easily obtain more detailed
information about the drug's approved uses and risks.
"Today's action can help promote greater consumer awareness
about prescription drugs," said FDA Lead Deputy Commissioner
Michael J. Friedman, M.D. "By describing realistic standards for
television advertising of prescription drugs, we hope to end the
uncertainty which has plagued both consumers and industry about
the use of this medium. The FDA is committed to making sure that
accurate and complete information is available to consumers."
Under the Federal Food, Drug and Cosmetic Act,
advertisements promoting the medical use of prescription drugs
must contain a "brief summary" of all important information about
the advertised drug, including its side effects,
contraindications and effectiveness. In addition, advertisements
broadcast over radio, TV or through telephone communications
systems must include a "major statement" prominently disclosing
all of the major risks associated with the drug.
In practice, print advertisements for prescription drugs
have been able to meet the "brief summary" requirement by
including the risk-related sections of drug labeling together
with the advertising copy. However, providing this amount of
information in television and radio advertising is far more
difficult, because of time and space constraints.
As a result, most broadcast prescription drug ads today only
mention the drug's name, but do not make any drug claims. Such
"reminder" ads are exempt from the "brief summary" requirement.
At the same time, existing FDA regulations allow TV and
radio advertisers to forego inclusion of the "brief summary" in
ads which make product claims if an ad makes "adequate provision"
for dissemination of the product's approved labeling.
In today's notice, FDA has developed a draft guidance
describing a practical approach for broadcast advertisers.
This new approach presumes that the broadcast ad is
truthful, not misleading, and contains information about the
major health risks associated with the drug.
In lieu of providing a "brief summary," the advertiser would
have to provide a mechanism to ensure that consumers can easily
obtain full product labeling. The draft guidance outlines one
possible mechanism for doing so, which includes the following
components:
-- providing a toll-free telephone number for consumers to
access detailed product information in a timely fashion -- either
by mail, fax or phone.
-- referring to direct-to-consumer print ads which contain a
brief summary of the product labeling. Reference to brochures
containing similar information would also be acceptable if the
brochures were distributed in a variety of publicly available
sites such as doctors' offices, libraries and stores.
-- providing an Internet web page (URL) address with full
access to the approved product labeling.
-- containing a statement that pharmacists, and/or
physicians/and or veterinarians (in the case of animal drugs) may
provide additional information about the product.
In addition to providing this information, the broadcast
advertisers are also being encouraged by FDA to provide consumers
with ready access to non-promotional, consumer-friendly
information about their advertised product.
FDA will continuously collect information on the broadcast
advertising that occurs as described in the draft guidance. FDA
is also urging broadcast advertisers and others to collect data
on the effect of such advertising and provide it to the agency.
The agency plans to evaluate the effects of this guidance within
the next two years to determine whether further refinements are
needed.
Those interested in commenting on the draft guidance may
contact FDA at the following address:
Dockets Management Branch
(HFD-305)
Food and Drug Administration
12420 Parklawn Drive, Room 1-23
Rockville, MD 20857, USA
In the meantime, the agency is developing a comprehensive
set of regulations for ensuring that consumers get accurate and
balanced information from all forms of prescription drug
advertising -- including broadcast, print, and other emerging
media.
--
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