Magazine article Drug Topics

Level the Field

Magazine article Drug Topics

Level the Field

Article excerpt

The Food & Drug Administration should not allow pharmacy benefit management firms owned by drug companies to make product claims that the drug manufacturer is forbidden to make. The same degree of regulation also should apply to PBMs under contract to a drug company,. the American Pharmaceutical Association and Glaxo Wellcome Inc. agreed in separate testimony at an FDA hearing last month.

ASHP told the same hearing--which was examining how drugs are being marketed to managed care organizations--at its survey of managed care pharmacists who buy drugs or manage formularies found four-fifths did not believe that the pharmacoeconomic claims made by drug manufacturers usually were highly reliable. "Obviously, this finding presents a big challenge for those interests that do not wish this matter to be regulated," observed William A. Zellmer, ASHP v.p. for professional and government affairs.

Many of the witnesses appearing at the public hearing were not in favor of FDA regulations aimed at the quality and reliability of drug information going to managed care organizations. Managed care organizations just don't need

FDA's

protection, said )Jonathan Lax, president of the market research firm The Marketing Audit. "They are smart," he continued, and the consequences of making "too many bad buys" will be that they'll go "out of business."

Mitchell E. Daniels J., head of North American pharmaceutical operations for Eli Lilly & Co., owner of PCS Health Systems Inc., the nation's largest PBM, said: "It would be unnecessary and moreover counterproductive for FDA to move beyond its critical and core mission to intrude upon this area." He suggested that managed care organizations were savvy purchasers and hard bargainers, capable of evaluating drug information without FDA assistance.

But Calvin H. Knowlton, president of APhA, advised the FDA not to be too sure about that. "FDA should not assume that managed care organizations are uniformly sophisticated purchasers," he said. "Managed care organizations are diverse, and lately many MCOs are in turmoil as a result of merger and acquisition activity." The ASHP survey, which had 157 responses out of 401 mailed questionnaires, seemed to bear out those concerns. …

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