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Drugmakers involved in potential off-label promotions of their products need to be wary of a new tactic used by prosecutors that has greater financial consequences than FDA enforcement activities under the Food, Drug and Cosmetic Act: prosecution under the False Claims Act.
Print and television ads for Aventis Pharmaceuticals’ leading allergy product made unsubstantiated superiority claims to other prescription remedies on the market, according to an untitled letter released by the FDA, which caused the firm to pull the ads in response, Aventis announced Jan. 14.
Off-label promotion, long a target of FDA enforcement activities under the Food, Drug and Cosmetic Act, has been garnering increased attention as a potential violation of the False Claims Act — with far greater financial consequences — according to healthcare compliance experts.
Several print and television ads for Aventis Pharmaceuticals’ leading allergy product have been pulled following the FDA’s assertion that the ads made misleading superiority claims over other remedies, the firm announced on Wednesday.
Drugmakers support the move by a major accreditor of continuing medical education (CME) providers to ensure that scientific experts aren’t excluded from CME programs based solely on their connections to pharma firms. However, they would like to see conflict of interest rules applied equally to nonprofit CME sponsors, according to an official at PhRMA.
A major accreditor of continuing medical education (CME) providers has announced that it does not intend to block physicians paid by drug companies from participating in CME events — a possibility that has raised considerable concern among manufacturers over the past 12 months.
As U.K. health regulators announce plans to increase scrutiny of antidepressant use and possible adverse reactions in adults as well as young people, industry observers do not expect the new study to affect profits.
The FDA has told Xcel Pharmaceuticals that its promotional materials for two migraine products omit risk information, make misleading comparative claims about safety and include unsubstantiated efficacy and indication claims.
The Biotechnology Industry Organization (BIO) wants the FDA to exclude promotional materials from its draft guidance on electronic submissions and develop separate guidance for advertising information that acknowledges the huge difference between ads and regulatory submissions.