FDA wants to hold Rx firms accountable for PBM Rx ads
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contracts with an unrelated PBM or influence over its promotional activities also would be held accountable, under a draft guidance the agency is circulating for public comment.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.
The FDA requires Rx manufacturers to provide it with copies of the promotional material they are disseminating. Burke said the agency was concerned that it was not receiving the promotional materials from PBMs, and the guidance would recommend that PBMs send them. In releasing the draft guidance, the agency disclosed that it is "aware that some benefits management companies that have business relationships with medical product sponsors are distributing product-specific information to P&T [pharmacy and therapeutics] committees (as well as to managed care professionals and patients) that is false or misleading and would be considered violative if distributed directly by the product sponsor."
The draft guidance is the outgrowth of an October 1995 FDA hearing on "Pharmaceutical Marketing and Information Exchange in Managed Care Environments." At that meeting, Rx firms that did not own PBMs argued that PBMs should not be allowed to say anything about Rxs that their owners could not say without facing an FDA rebuke. The FDA expects to issue more managed care industry guidance documents, which represent the agency's current thinking on its regulations and authority, under the general heading of "Promoting Medical Products in a Changing Health Care Environment." The FDA will accept comments on the PBM draft guidance until April 6