Parallel FDA/CMS Review Is Poised for Prime Time - But Is Anybody Biting?
The device industry has long complained about the lengthy, separate review times required to achieve FDA and CMS clearance. Finally, the two agencies are working together on a pilot program to make this process faster and more efficient. Industry's response: not so fast. Despite the apparent advantages parallel review can offer to product companies, industry has been cautious and slow to respond out of concern for protecting proprietary data and the possible need for more complex clinical studies. Parallel review may represent an example of regulators being ahead of industry in streamlining the regulatory process, and the burden will be on FDA and CMS to demonstrate the true value of this approach.
You may also be interested in...
Exact Sciences, one of the first companies to volunteer for a pilot program launched in 2011 testing FDA-CMS parallel review, says its experience with the process so far is very positive. Agency officials are planning to review experiences with the program to make improvements.
The possibility of simultaneous FDA and CMS evaluations of new devices is back in the front of agency officials' minds after a series of fits and starts over the past several years, says CMS Chief Medical Officer Barry Straube
The story of the successful development by Cordis Corp., a Johnson & Johnson operating company, of the first drug-eluting stent, the Cypher, and its introduction this year into the US market has been well chronicled. What is not as well known is the equally successful and ground-breaking work that Cordis did in obtaining incremental reimbursement (an increase over the existing reimbursement level for bare metal coronary stents) for the Cypher stent from Medicare prior to the device receiving FDA approval. This is an interview with the person who directed Cordis' reimbursement efforts for the Cypher stent, Brian Firth, MD, PhD, VP for medical affairs and health economics, who explains how Cordis developed and implemented its reimbursement strategy for Cypher, and the implications of this approach for future new technologies.