Safer harbor

How new FDA guidance could clear one of the obstacles to outcomes-based contracts

FDA guidance released on June 12 clears up regulatory ambiguities that have restricted drug and device company communications with payers, physicians and patients. A primary goal is to make it easier to base payments on outcomes not mentioned on product labels, but there could be broader effects in the loosened restrictions on communications between medical product developers and payers.

If sponsors exercise the ability to discuss healthcare economic data before drugs are approved, that could prevent payers from being surprised by high demand, as they were for the HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc.

The guidance also should support use of and encourage studies to develop non-clinical data, such as quality-adjusted life years (QALYs) and reduction in hospital admissions or stays.

And if the Department of Health and Human Services (HHS) takes steps to remove regulatory impediments outside FDA’s jurisdiction, the guidance will enable payers and medical product manufacturers to experiment more broadly with alternative reimbursement arrangements, including outcomes-

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