Jeffrey E. Shuren, M.D. Image courtesy of the FDA. |
In order to improve review times and the quality of device reviews, and in response to calls from the medtech industry, Shuren also said that the agency will be implementing a network of experts and experiential learning programs, leveraging existing networks from healthcare and scientific professional organizations, to enhance the expertise at the CDRH.
The passage of MDUFA III was a boon to both the FDA and medtech companies. Although companies will now pay higher user fees, they ostensibly will receive a more efficient review process for their devices in exchange.
“Regulatory science,” explained Shuren, is a slippery term. It provides tools, standards and approaches needed to evaluate safety, effectiveness, performance and quality of medical devices. It benefits patients by getting technology to market more quickly; it reduces the time and resources needed for device development, assessment and review. However, Shuren noted, funds tend to be funneled into what is perceived as “real” science instead of regulatory science due to a lack of understanding of the value regulatory science provides. “We need to be pooling our resources,” Shuren said.
An audience member took Shuren to task on the agency’s difficulty in retaining talent. The FDA and CDRH typically experiences a high personnel turnover rate, thanks mostly to the struggle for funding.
“It is a big problem,” conceded Shuren. “Our turnover rate runs at about 8 to 9 percent. The whole review process takes years, so your lead reviewer may not be there by the end. It can lead to longer reviews. We have to address the real drivers. People feel they have too much on their plate, and leave.”
Having “too much on your plate” is directly related to salary, and government simply cannot compete with private industry pay. However, the reauthorization of MDUFA should help with that problem, funneling more money into the agency. Currently, Shuren said, the ratio of frontline managers to staff can be as high as 27 to one, which can “lead to disaster.” Reorganization efforts at the CDRH is aimed to bring that ratio down to between 10 and 14 to one.
On March 1, when the U.S. government was forced into sequestration when it did not reach an agreement on budget cuts, the FDA risked losing funding of about $206 million. Part of those cuts limited the agency’s access to user fees paid by medtech companies. However, U.S. Senate and House lawmakers were able to avert the crisis by passing a continuing resolution that will at least hold up the agency until September. The goal is for the Senate to come up with a permanent budget solution by that time.