A High Wire Balancing Act: FDA and CMS to Consider Parallel Review of Medical Products

By Jeffrey N. Wasserstein & David B. Clissold –

In a move that signals the future of medical product development, the Food and Drug Administration ("FDA") and the Centers for Medicare and Medicaid  Services ("CMS") announced that they are considering establishing a parallel review process for reviewing and evaluating premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. The stated goal is to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations ("NCDs").  Currently, medical products undergo two reviews: the first by FDA to determine if the product may be approved or cleared and a second review by CMS to determine whether it will be covered by Medicare. 

Implicit in the proposed parallel review function, however, is the potential that use of comparative efficacy data in making NCD decisions may have a spillover effect on FDA approval issues.  The initial focus of the program appears to be on medical devices, but the process will have implications for drugs and biologics as well.

The two agencies have opened a docket to receive comments from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how the considered parallel review process should be implemented, and other related issues related to the effective operation of the process.  The Federal Register notice asks 17 specific questions, including, most critically:

• Should anyone other than the product sponsor be able to initiate a request for parallel review (for example, the FDA, CMS, an interested third party)?

• For which classes of products would consumers, payers, or sponsors benefit most from parallel review?

• Should CMS be permitted to review indications for which the sponsor is not seeking FDA clearance or approval under parallel review (that is, off label indications)?

• Are there any barriers (for example, regulatory, legal, scientific) to parallel review and if so, how might they be overcome?

• Should a voluntary process be put in place to encourage the conduct of clinical trials that are appropriately designed to support both FDA approval/clearance and CMS national coverage decisions? If so, what process should be established?

• What criteria should the FDA and CMS use to decide whether to grant a request for parallel review?

• Should the agencies offer joint meetings to sponsors?  Joint advisory committees?

• Should FDA and CMS have access to the same data and information about the product during parallel review?

• Once FDA and CMS have opened a parallel review should a sponsor be able to terminate or withdraw the request for parallel review? If this happens, should that information be made public?

The agencies also announced their intent to create a pilot program for parallel review of medical devices once they’ve received and reviewed public comments.  Comments to the docket are due by December 16, 2010.