Report Sees Progress and Challenges for CDRH
The U.S. Food and Drug Administration (FDA) office responsible for the oversight of medical devices is making significant strides towards better meeting its scientific mission, but it will take years before many reforms are fully realized.
The assessment of the Centers for Devices and Radiological Health (CDRH) is detailed in a new report, The State of the FDA Workforce, released this month and prepared by the Partnership for Public Health Service, a nonprofit organization that focuses on revitalizing the federal government. The report is a follow-up to a 2007 report by the FDA Science Board that concluded the FDA was ill-equipped to deal with “escalating demands” on its resources and advances in science and technology.
The new report says the FDA has “made progress” since the 2007 findings, but “continues to have significant workforce and management challenges” that impede its ability to “fulfill its public health obligations to the American public and its responsibilities to the industries it regulates.”
There is a chapter of the report devoted to the CDRH.
“Like many regulator organizations, CDRH has been routinely criticized by both industry and consumer advocates,” the report says. “The former group has generally pushed to streamline and speed up the regulatory process—particularly in the premarket phase—while the latter has often sought more checks on safety through tighter regulation of medical devices.”
In that environment, the report found a staff “dedicated to the center’s mission and their work,” one keen on ensuring that marketed medical devices “are safe and effective” and supportive of “innovation in the development of new and more effective medical devices.” The report makes note of a sweeping strategic plan unveiled by CDRH in 2010 to improve the review process for medical devices. The review process has been the subject of considerable criticism by manufacturers who have called it unpredictable, confusing, and needlessly long. Parts of that strategic plan have been implemented, including the establishment of a core curriculum for product reviewers and making that training mandatory for new reviewers. Still, the report concludes that “it’s probably unrealistic to expect major impacts” in the short term and that the office faces a host of other challenges.
“These include resource constraints and heavy staff workload; difficulties recruiting and developing employees; deficits in emerging science and technology areas; inconsistencies and inefficiencies communicating with stakeholders externally and internally; and high attrition rates in core positions,” the report reads. In fact, the attrition rate for CDRH employees is well above that of all FDA employees, 9.7% compared to 4%. A survey of FDA employees underscores the workforce challenge faced by CDRH. Asked to evaluate the statement, “My workload is reasonable,” 59.7% of all FDA employees offered positive response, but only 49.7% of CDRH employees did the same.
Interestingly, though, 74.7% of CDRH employees indicated satisfaction with their jobs, compared to 69% for all employees. The report says that the CDRH employees are one of the key strengths of the entire office.
“Employees are passionate about their work and their ability to have an impact on public health at a national level,” the report reads.
Looking ahead, the report makes several recommendations for the FDA as a whole, including improving the recruiting and hiring process, and holding agency leaders accountable.
To read the full report, click here.
Posted: November 26, 2012