On Friday, September 17, 2010, the Department of Health and Human Services (HHS) released notice of its intention to consider a parallel regulatory and reimbursement review process that could result in simultaneous marketing clearance from FDA and Medicare national coverage for new medical products. A copy of the notice is available by clicking here. Public comments are due by December 16, 2010. The notice also announces the intent to create a pilot program for parallel review of medical devices once the agencies have reviewed comments submitted.

A parallel review process would permit the premarket review process of the Food and Drug Administration (FDA) and the national coverage determination (NCD) process of the Centers for Medicare and Medicaid Services (CMS) to proceed concurrently. This unprecedented interagency coordination could, theoretically, shorten total time required between FDA marketing approval or clearance decisions and CMS coverage determinations. CMS and FDA's stated goal for this process is to improve public health by "speeding consumer access to and spurring the development of new, affordable reliable, safer and more effective medical products and services." They note their concern about existing barriers to bringing innovative medical products to market and resulting barriers to access for patients.

The agencies are soliciting comments on 17 issues identified in the notice in order to develop joint draft guidance and implementation procedures for each agency. Issues worthy of consideration and comment by industry, investors, patient groups and others include:

  • What legal, regulatory and/or scientific considerations pose barriers to the implementation of parallel review process?
  • How will the agencies balance transparency of their processes with industry concern about confidentiality of proprietary information?
  • How would resource limitations at both agencies limit the number of concurrent reviews? What classes of products should be prioritized?
  • What criteria would the agencies use to grant parallel review?
  • Who would be able to initiate a request for parallel review: industry sponsors, CMS, FDA or other interested third parties?

In addition to the specific issues listed above, industry may be interested in early development of cross-agency data needs. Such an understanding could allow a sponsor to develop FDA required data and CMS required data in one study, rather than delaying broad patient access in order to collect additional data that CMS requires for coverage and payment. As one contemplates such parallel processing, two broad sets of questions emerge:

  • Is parallel FDA and CMS review something that could shorten product development and marketing timelines, reduce the cost of bringing new products to market and ensure broad patient access?
  • What procedural issues and challenges will such an approach create? Will a parallel process slow either FDA approval decisions or CMS coverage decisions as one agency waits for the other or seeks to link data analysis? Will a parallel process result in FDA considering coverage matters or economics in product approval decisions?

This approach may also create greater linkages between FDA and CMS in setting post approval data collection requirements. One can imagine REMS-type studies or post approval PMA conditions-of-approval studies that include cost data in addition to the more traditional safety and efficacy data.

Overall, this idea merits serious thought by all stakeholders. Is it a way to accelerate patient access to new medical products or an additional bureaucratic process that will increase the cost of research and development and extend timelines for marketing clearance, national coverage and payment?