FDA Commissioner Announces Expansion to Program Intended to Speed Access to Medical Devices

FDA Commissioner Scott Gottlieb, M.D. recently announced in a blog post that the FDA, building on its experience with joint parallel review process with CMS, has expanded its “Private Payer Program.”

Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), recently announced in a blog post that the FDA, building on its experience with joint parallel review process with the Centers for Medicare & Medicaid Services (CMS), has expanded its “Private Payer Program.”  This program is designed to provide device manufacturers with feedback from FDA and private payers, respectively, on their evidence generating plans during product development, potentially reducing the time from design to regulatory clearance and approval, and ultimately, to payer coverage.  With this announcement, eight payer and health technology assessment organizations now participate in the program.  When requested by the product developer, payers will work with the FDA during the pre-submission meeting process to facilitate and enhance communication with manufacturers regarding the types of evidence that will likely be needed for regulatory clearance and approval and positive payer coverage decisions, respectively.

 

In his blog post, Dr. Gottlieb acknowledges that the process of obtaining FDA clearance and approval and payer coverage can be lengthy and burdensome, particularly for smaller manufacturers, but notes that the Private Payer Program will help to streamline communications and reduce unnecessary delays in the FDA and payer review processes.  He believes that this in turn will provide the potential for earlier reimbursement through enhanced engagement with private payers.