Washington, DC — In the United States, the intricate process of approving drugs for the marketplace and authorizing payment falls under the purview of two federal regulatory agencies: the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS). Recognizing the natural connections between these agencies, BPC, with the support of Arnold Ventures, released a policy brief this morning outlining practical, bipartisan, and achievable steps to improve information sharing between the agencies.
The brief, Strengthening Regulatory Collaboration Between FDA and CMS, underscores the distinctive roles of FDA and CMS within the Department of Health and Human Services (HHS) and emphasizes the need for enhanced coordination by improving information sharing. Most of the recommendations do not require congressional modifications to existing statutes governing the agencies. Instead, they focus on establishing a more balanced flow of information to facilitate collaboration between the FDA and CMS.
Recommendations fall into four categories: sharing drug and biologic information; clarity in post-market data and accelerated approval; improving coordination with Medicaid; and cross-agency training.
By evolving the regulatory processes and heightening coordination, Medicare and Medicaid beneficiaries, as well as numerous other health care recipients will see more prompt access to therapies while the agencies maintain their respective statutory requirements.
Full brief available online.