FDA, CMS Make ‘Parallel Review’ Program Permanent
FDA and CMS have announced that their ongoing medical device “parallel review” pilot program will be fully implemented and extended indefinitely. Parallel reviews allow both agencies to review information about a medical device concurrently, rather than sequentially, while continuing to make their premarket review and coverage decisions consistent with their respective statutory authority. The agencies say they are now soliciting nominations from manufacturers for innovative medical devices to participate in the program, according to a just-posted notice.
Launched in 2011 (see story), the pilot anticipated approving medical devices concurrently for both market entry review for FDA approval and Medicare coverage. “The FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies,” an agency news release said at the time. “Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.”
During the pilot, the agencies say they learned that device manufacturers benefit from engaging both agencies at the pivotal clinical trial design phase. “The feedback that manufacturers receive from both agencies at the pivotal clinical trial design stage can assist manufacturers in designing pivotal trials that can answer both agencies’ evidentiary questions,” they say. “Thus, it is more likely that manufacturers will only need to conduct a single pivotal clinical study rather than several pivotal clinical studies to satisfy both agencies.” They also found that concurrent review by the agencies of clinical evidence can reduce the time from FDA premarket approval or the granting of a de novo request to a CMS coverage decision.
Meanwhile, a new study from George Mason University’s Mercatus Center contradicts the agencies’ conclusion that the pilot has been successful, contending that it had fallen short and “failed to address the real obstacles manufacturers face in getting medical devices to patients.” The study acknowledges that this seemed logical at the time, but concludes that “based on very little demonstrated interest in the FDA-CMS parallel review program, doing so for new medical devices has not worked. Despite this lack of interest, however, regulators have expanded the program to private payers to enable reimbursement from private insurers as well as from Medicare. Instead of creating a process within the confines of existing regulatory structures at the FDA and CMS, policymakers should focus on real reform within the agencies themselves to provide much-needed relief for manufacturers who develop innovative medical devices and forthe patients who use them.”
The study says that the parallel review process does nothing to address obstacles already facing manufacturers. “It does not encompass all regulatory procedures that must be completed, nor does it address flaws within the existing FDA and CMS approval procedures,” it says. For example, the study says parallel review does not address “unpredictability” within FDA’s approval process, which already costs manufacturers around $94 million per device. “A recent survey found that disruptions and delays in the premarket approval process, such as key personnel changes and agency representatives absent from key meetings with companies, were common.” it says. “Forty-four percent of survey respondents reported personnel changes partway through the PMA process, and 34% reported meeting absences.”