US Drug Cos Warned Not To Pressure GPs

Eli Lilly, Merck & Co and SmithKline Beecham have been warned by the US Food and Drug Administration not to pressure doctors to prescribe their drugs for unauthorized treatments or to withhold "sufficient disclosures regarding the risk" of adverse side effects, according to the New York Times.

The agency, the concerns of which center around worries that the companies would abuse the power of the Pharmaceutical Benefit Managers they have acquired, sent a formal comment to the Federal Trade Commission, which is reviewing the $4 billion Lilly purchase of PCS. A group which opposes the acquisition sent a copy of the letter to the NYT. The letter noted that the agency feels "health care providers and patients need to obtain truthful, scientifically-based and non-misleading information about pharmaceutical products," and asked the FTC to help "safeguard and clarify the marketing and communications aspects of these mergers."

While the FDA has discussed these concerns with the companies involved, it is not trying to block the Lilly/PCS deal, but rather is trying to keep the marketplace honest as it changes, according to FDA Deputy Commissioner Mary Pendergast. While there has been strict enforcement of a ban on promotion of unapproved uses, there is nothing which prohibits a doctor from prescribing off-label uses. With continued vertical integration, the agency is concerned that drug companies may find new ways to circumvent these legal requirements, she added.