CDRH Navigates Tricky Terrain Post-Government Sequestration

This year, the Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA) will be focusing, predictably, on implementing the Food and Drug Administration Safety and Innovation Act, signed into law on July 9, 2012; achieving the medical device user fee amendments (MDUFA III) performance goals; and releasing guidance on pre-submission meetings, refuse-to-accept and refuse-to-file criteria, and eCopy rules, said CDRH Director Jeffrey E. Shuren (pictured left), M.D., J.D. this week at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C.

These have been the regulatory body’s expected goals since last year. In the next few weeks, however, Shuren said the industry can look forward to guidance documents on early feasibility and investigational device exemption (IDE) approvals. “We’ve realized that as technology become more complex, 90 days for an IDE review is not sufficient,” he said. “We’d like a pathway that builds in a little bit more time beforehand, but will ultimately be more efficient.”

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, enhance the expertise at the CDRH.

The passage of MDUFA III was a boon for both the FDA and medtech companies. Although companies will now pay higher user fees, they will ostensibly 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 to device development, assessment and review. However, Shuren lamented, 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, not least because of 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 this year, when the U.S. government was forced into sequestration when it did not reach an agreement on budget cuts, 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, 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 at that time.