The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced Friday that they will now review products simultaneously under a new parallel review program.
This is a sharp contrast to current practices, wherein Medicare frequently does not commence its reviews until the FDA -- which is supposed to ignore cost consideration in assessing products—gives its stamp of approval. Whether or not a medical product garners Medicare approval and, in turn, Medicare coverage is a critical factor in its success.
Proponents of the pilot program believe it could help device makers avoid situations in which they receive FDA approval, only to learn that their products have indeed failed to win coverage under Medicare.
"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," says CMS Chief Medical Officer Patrick Conway, MD. "Our goal is to reduce regulatory burden and improve patient outcomes.”
The Advanced Medical Technology Association (AdvaMed), which represents device makers, says it continues to scrutinize the program's details. However, it has made known its support of any effort to render reviews more timely, predictable, and efficient.
"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," asserts Ann-Marie Lynch, AdvaMed's executive vice president of payment and health care delivery.
The FDA and CMS say the "parallel review" process will not alter their distinct standards. Both agencies have already begun to accept submissions for participation in the pilot program, which is voluntary and was proposed in September 2010.
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