Last month, FDA and the Centers for Medicare and Medicaid Services (CMS) issued a Federal Register notice soliciting comments on a proposal to establish a process for the parallel review of drugs and devices for FDA marketing approval or clearance and CMS national coverage determinations (NCDs). The goal for parallel review, as articulated by the agencies, would be to speed consumer access to new medical products and spur the development of better products. Under the current regulatory scheme, FDA determines product safety and effectiveness for marketing before the manufacturer seeks product coverage. Manufacturers have found this two-step process to create a lag time for consumer access to new medical products while they obtain third-party payer coverage for their products. The product review processes and information evaluated by FDA and CMS in reaching their respective product decisions vary greatly. While FDA reviews clinical and technical data specific to the product and product use under review, CMS reviews outcomes data (including whether the product provides improved health outcomes over alternative treatments covered by CMS) and also examines off-label product uses in reaching its NCDs.
Parallel review runs the risk of expending CMS resources for review of medical products that will never achieve FDA marketing approval or clearance and expending manufacturer resources in preparing NCD submissions that CMS may never issue. However, the agencies believe that a parallel process could create efficiencies in educating sponsors and manufacturers on study designs that will meet the review criteria of both agencies and ultimately speed the agencies' respective review and determination processes for the benefit of consumers. FDA and CMS have proposed to pilot the parallel review process first with developers of medical devices with participation information to follow at a later date. The agencies envision that a manufacturer would request parallel review and obtain the agreement of each agency to proceed with parallel review. Note that due to the statutory requirements under which CMS operates, FDA's marketing decision still would precede CMS's NCD. The agencies are soliciting comments from interested parties on a number of questions related to the parallel review of products, given that this process would need to be fleshed out for industry (e.g., the criteria FDA and CMS should use in granting parallel review requests, the time point during FDA review in which CMS review should commence, joint agency access to data and other considerations for implementing such a process). Although the public comment folder currently is empty, interested parties have until December 16 to submit comments on this proposal.