Magazine article Drug Topics

Under Watch

Magazine article Drug Topics

Under Watch

Article excerpt

Pharmaceutical companies may have to start watching what the pharmacy benefit management firms they own say about their medicines-or face a crackdown by the Food & Drug Administration. The agency is considering holding drug manufacturers responsible for a PBM subsidiary's false or misleading Rx marketing efforts or promotion of unapproved uses. In some instances, Rx makers that have contracts with an unrelated PBM or influence over its promotional activities also would be held accountable, under a draft guidance the agency is circulating for public comment.

"While PBMs can be useful tools for managing health-care costs, the FDA wants to ensure that patients are not put at risk by improper marketing practices," said Michael Friedman, FDA lead deputy commissioner. The agency expressed concern about drug switching spurred by rebates or other financial incentives because of Rx company ownership or partnership with PBMs and other health-care organizations. "This practice could have serious health implications for patients-particularly those dependent on chronic therapy-if medical decisions are influenced by incorrect or misleading information," said the FDA.

Laurie Burke, an official with the FDA's drug marketing, advertising, and communications division, told Drug Topics that the agency had received "some" reports of adverse events related to drug product switching but could not "estimate the risk." But Burke said that there is a health risk associated with Rx decisions being based on inappropriate promotional information. …

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