AHEAD FOR FDA: PUSHES FOR REFORM, LOOSENING OF DRUG ADS

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Pharmaceutical companies have two resolutions on their list as they head into the New Year-they want the ability to more easily advertise prescription drugs to consumers and permission to tell doctors about other uses for drugs. Making those resolutions a reality may be tough, however.

Though prospects for direct-to-consumer advertising reform appear somewhat better this year-as lobbying moves forward and a new Food & Drug Administration commissioner is appointed-a final answer on the issue remains uncertain.

FDA ad rules were written long ago, and the phenomenon of advertising prescription drugs to consumers is causing much confusion. Print ads, for example, must include the mandated "brief summary" of a drug's contraindications-an indisputable misnomer that often requires a page or more of clinical data in small type. Equally as baffling to consumers, marketers are forbidden from revealing in the same TV spot both the brand name and the condition the drug treats.

The Coalition for Healthcare Communication, an ad group that includes the American Association of Advertising Agencies, is now pushing to replace existing rules with the use of a disclaimer for print or broadcast ads similar to the familiar surgeon general's warning on tobacco ads.

For example: "Prescription drugs can be harmful if not used correctly. All patients are different and (product name) may not be right for you. Only a physician can advise you about using (product name). Never take prescription drugs without a prescription from a physician."

CONGRESS EYES AGENCY

Ad groups say the FDA, being attacked for everything from delayed approval of drugs and devices to meddling in tobacco advertising, may get a thorough examination by Congress, which has been seeking reform of the agency.

"There will be a lot of activity" on FDA reform, predicted Dan Jaffe, exec VP, Association of National Advertisers.

These issues could surface in hearings on the FDA or in the confirmation proceedings for a replacement to outgoing FDA Commissioner David Kessler.

Last May, the FDA responded to industry complaints about its drug ad rules by asking for public comments on proposed changes. At the same time, the agency proposed allowing drug companies to substitute disclosure information contained in FDA-approved package inserts for the much more technical disclosure information now required.

The government agency received 25 comments, including one from the Federal Trade Commission staff urging it to loosen the rules and set up different disclosure requirements for print and broadcast.

"Through courts or through the FDA or through Congress, we are hopeful

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