DTC DRUG ADVERTISING CHANGES UNLIKELY

Legal Panel Says Industry, FDA Have No Common Ground

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NEW YORK (AdAge.com) -- Despite public hearings by the Food and Drug Administration and groundswell of criticism from the public and Congress, little is expected in the way of change for direct-to-consumer drug advertising.
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Three lawyers
That’s the conclusion of three legal experts at a media briefing and Webcast by the Washington Legal Foundation this week called “Regulating Drug Promotion: Assessing a Tumultuous 2005 and Prospects for the New Year.”

“There was so little common ground” at the FDA’s November public hearings with the drug industry “that I suspect nothing will happen,” said Richard Samp, the foundation's chief counsel. The other two participants were David J. Bloch, a partner in the Washington law firm Reed Smith, and Adonis Hoffman, senior VP-counsel for the American Association of Advertising Agencies.

Stumbling blocks
Mr. Samp said there are major stumbling blocks to a proposed code of conduct drawn up by the drug industry’s trade group, the Pharmaceutical Research and Manufacturers of America. Part of the code requires pharmaceutical companies to submit DTC ads to the FDA, which he said is fraught with problems.

“I don’t think pre-clearance is ever going to work, because the FDA is never going to say that ‘Once we have seen the ad and not objected, we waive our right to object’” in the future, he said.

Mr. Samp said the pre-clearance guideline is dubious, because neither the FDA nor the pharmaceutical companies will come to an agreement on this issue unless drug makers are given assurances against a form of double jeopardy. That is, if the FDA approves marketing for a drug in the pre-submittal process, it cannot come back later and hand out a warning letter for a product that it has already approved.

“That’s the only grounds on which any pharmaceutical company would ever agree to any pre-clearance, that they would get some sort of ‘safe harbor’ if they did so,” Mr. Samp said. “And no amount of resources at DDMAC [the FDA’s Division of Drug Marketing, Advertising and Communication] is ever going to put FDA in a position of agreeing to this kind of safe harbor.”

'Another ball in the air'
Mr. Bloch said pharmaceutical companies need to be wary of issues such as potential liability under the False Claims Act and suggestions of a one- or two-year moratorium on advertising after a product hits the market. “None of this has gone terribly far,” he said, “but it’s another ball in the air to watch as things progress.”

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