The Food and Drug Administration (FDA) will review new products in parallel with the Centers for Medicare and Medicaid Services (CMS), the agencies said on Friday.
The pilot program could help device makers avoid situations in which they receive FDA approval only to discover that their products fail to win coverage under Medicare, the federal insurance program for the elderly.
Currently, Medicare often does not begin its reviews until the FDA -- which is not supposed to take cost into consideration -- approves the products. A Medicare coverage decision can make or break a medical product.
"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," CMS Chief Medical Officer Dr. Patrick Conway said in a statement. "Our goal is to reduce regulatory burden and improve patient outcomes."
The Advanced Medical Technology Association (AdvaMed), which represents device makers, said it was still looking at the program's details but supported any effort to boost timely reviews that are more predictable and efficient.
"However, we believe it is important to preserve the currently separate and distinct regulatory missions of FDA and CMS to ensure that each agency does not influence the functions and decisions of the other and to ensure the confidentiality of all proprietary information provided by manufacturers," Ann-Marie Lynch, AdvaMed's executive vice president for payment and healthcare delivery policy, said in a statement.
The FDA and CMS said the "parallel review" process will not change their distinct standards. The agencies on Friday began accepting submissions for participation in the pilot program, which is voluntary and was proposed in September 2010.
More information is available on the FDA website, at http://1.usa.gov/qKuRJr.
By Alina Selyukh
Last Updated: 2011-10-07 16:40:02 -0400 (Reuters Health)
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