Many companies and individuals have commented that they are opposed to the idea, out of concern for sufficient review and an expedient process. But CMS and FDA officials say they intend that the parallel review will "focus attention on health outcomes of importance to Medicare, and provide early awareness of any remaining evidence gaps." If there are gaps, the CMS may implement an evidence development policy, covering the device only within certain parameters of a post-approval study.
"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes," Patrick Conway, MD, CMS' chief medical officer, says in a statement. Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health, adds that the program will make the process work "efficiently for expedient patient access to safe and effective medical devices."
The pilot program will last up to two years and will accept no more than three to five submissions per year. The emphasis will initially be on medical devices but the agencies say they will use the experience to develop similar pilots for drugs and biologics. Eventually, the agencies hope the program will "inform guidance for a broader program applicable to all medical products."
The announcement comes one year after the FDA and CMS announced their intention to implement the review process. But several individuals and companies have posted comments on Regulations.gov that the parallel review was necessary, and that changing the process in fact may slow down reviews.
For example, Genentech's vice president of government affairs, Evan L. Morris, wrote: "if CMS requires data for its review that are not required in the FDA clearance or approval process, the manufacturer might be required to submit additional data that could prolong the parallel review process as well as potentially requiring both the manufacturer and the Agencies to devote more resources to the review than was originally anticipated."