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It's time to change the rules for drug approval and direct-to-consumer advertising, the American Association of Advertising Agencies and others contend.

Long dissatisfied with the Food & Drug Administration's murky rules about direct-to-consumer advertising, the Four A's has begun circulating its own plan in Congress. The group would also like the FDA to stop having jurisdiction over both drug approval and drug advertising.

Calling the rules "overly complex, expensive and detailed burdens," the proposal recommends the FDA "abandon all attempts to regulate marketing of prescription drugs and devices where the FDA and Federal Trade Commission have overlapping jurisdictions."

Currently, both may have the authority to regulate prescription drug advertising, but Congress currently relegates power over direct-to-consumer ads to the FDA. The FDA rules require disclosure of all warnings, side effects and contra-indications, or an equivalent, in each ad in a "brief summary."

Such print ads usually require twice as much space as typical over-the-counter ads. And broadcast ads must be either "reminder" ads, which can mention the name of the product but not the condition it treats, or "health message" ads, which can only mention the condition and not a product.

"What everybody misses is that the consumer can't get the drug without the intervention of the doctor," said Win Gerson, chairman-CEO of William Douglas McAdams, a New York pharmaceutical agency.

According to some, the FDA also now implicitly requires a pre-clearance review of direct-to-consumer ads.

"A system which depends on pre-clearance is inherently chilling and inconsistent with the First Amendment," wrote Jim Johnstone, acting counsel to the Four A's, in a report.

The FDA denies requiring pre-clearances, but said that it does ask manufacturers to "voluntarily submit" the ads for review.

Due to the FDA's dual responsibilities of drug and ad approval, "there is a perception in the drug industry that there is a potential for vengeance by the FDA," Mr. Johnstone said.

Drug companies and their ad agencies are reluctant to cite specific examples of intimidation for fear of retaliation by the FDA.

Such charges are "innuendo with no documentation," said Dr. Nancy Ostrove, an FDA public health analyst.

This concern has caught the ear of Congress. In response to testimony on the same subject last month by FDA Commissioner David Kessler, a congressional subcommittee sent a letter on May 22 to Mr. Kessler noting "While we appreciate your assurances .*.*. that such fears are unfounded, we would appreciate learning what affirmative steps the FDA will take to reassure those regulated by the agency that they may feel completely comfortable exercising their right to speak freely to the Congress, without threat of retribution or retaliation."

The letter was sent by Thomas J. Bliley Jr. (R., Va.), Joe Barton (R., Texas), John Dingell (D., Mich.) and Ron Wyden (D., Ore.).

Mr. Kessler's office has not yet responded.

Nonetheless, direct-to-consumer ads are on the rise, up 47% to $240.7 million in 1994, according to Competitive Media Reporting. That number is expected to continue rising.

The Association of National Advertisers, which has spoken out against the FDA policy, is developing a formal position on the issues; the Pharmaceutical Research & Manufacturers of America is expected to soon reach a position on the issue.

The direct-to-consumer ad issue has been around since the early 1980s, when the FDA called for a moratorium on the then-new form of advertising until it could decide how to regulate it. "Reminder" and "health message" ads were allowed on broadcast, while it referred print ads back to 1969 regulations on prescription drug advertising, which required "brief summaries."

These requirements, said the Four A's, were intended for medical journals, not consumer media. The FDA later lifted the moratorium but never issued new rules.

Dr. Ostrove said the agency has been studying the issue since '91, but could not say when or if changes would come.

Reforms aren't expected for at least a year, but could include the FDA surrendering its drug ad jurisdiction to the FTC, which is considered more lenient. Or the FDA could simply issue more specific rules.

Andrea Sachs contributed to this story.

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