March 1, 2012

Last year, CMS and the FDA launched a pilot program for concurrent regulatory and reimbursement review of medical products. While manufacturers may like the idea of reducing the cycle time between FDA and CMS reviews, there are downside risks — for example, that CMS’ reimbursement concerns may become an element in the FDA’s determination of the product’s safety, efficacy, and market clearance.

In their post, What Parallel Review Means for Manufacturers, published this month on BIOtechNOW, the blog of BIO, the Biotechnology Industry Organization, NAI consultant Stephen R. Rothenberg, J.D., and business analyst Matt Levy, J.D., explain the implications of parallel review for manufacturers — and describe how manufacturers can respond to ensure the continued success of their products.