HHS NEWS

P97-26                        FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE         Bradford Stone  (301) 827-6242

August 8, 1997                

                              



  

        FDA TO REVIEW STANDARDS FOR ALL DIRECT-TO-CONSUMER

                        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

     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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