The FDA’s Internal Employee Struggles
November 26, 2012 ~ The U.S. Food and Drug Administration (FDA) is a large public agency that regulates consumer products that make up about $1 trillion in annual spending or 25 cents of every dollar spent on food, cosmetics, drugs, medical devices and tobacco products.
The Partnership for Public Service supported by the Pew Charitable Trust interviewed about 30 insiders to make up its just issued report, “The State of the FDA Workforce.” The report is here.
As means of history, in 2007, a report by the FDA Science Board subcommittee on science and technology found the agency is not able to keep pace with advances in science concerning the very products it is supposed to regulate. Employee turnover was high due to the intense work pressures and finding new hires was increasingly difficult.
The Center for Devices and Radiological Health (CDRH) which approves medical devices, was found to have the highest employee turnover within the agency of 9.7 percent. It also has the second highest number of employees at 2,132, following CDER at 3,926. The CDRH was formed in 1982 as part of a bureau reorganization merging the Bureau of Medical Devices and the Bureau of Radiological Health.
The FDA has been the subject of unflattering complaints from whistleblowers within the agency who said they were pressured to approve products and medical devices that their scientific expertise said should not be approved. The FDA is told it does not approve drugs and devices fast enough while the public claims it is an arm of the very industries it is supposed to regulate.
Page 33 of the report goes on specifically about the CDRH. Headed since 2010 by Dr. Jeffrey Shuren, the CDRH seems to be the most troubled department within the FDA with the highest attrition rate and plagued with poor communication and expectations.
This spills over into the review process where the report says employee problems affected the pre-market and approval of medical devices.
The problems included:
*High workloads for reviewers and frequent delays in processing requests
*Spotty staff knowledge of the 510(k) review process, resulting in inconsistent decisions
*Inadequate supervision of reviewers
*Poor reviewer communication with industry submitters, particularly in clarifying review standards, expectations and the basis for CDRH decisions
*High reviewer attrition rates—double the rates found elsewhere at the FDA
A culture change is underway within the agency the report says, though never directly addresses the conundrum – when the public interest and industry interest collide how is that resolved? It’s difficult to serve under two masters.
“Today only a small percentage of all medical products require intensive pre-market review and testing by CDRH,” instead delaying on the expedited 510(k) approval process,” admits the report.
After the 2007 report, Congress increased the FDA’s annual appropriation to $2.5 billion in 2012 up from $1.5 billion in 2007, a nearly 60 percent increase. The user fee from industry makes up about 44 percent of the total budget or $2 billion.
The workforce expanded from more than 11,000 employees in 2007 to nearly 15,000 in 2010, an increase of 31.5 percent. Industry expected more cooperation for its additional funding and the agency was given the additional task of regulating tobacco and inspecting foreign food and drug facilities and increasing inspections of domestic food sources.
The recruiting of scientific talent was returned to the FDA and in July the agency set up the Office of Human Resources. Problems include a lack of mentoring within the agency, loads of paperwork and a slow hiring process, often leading qualified applicants to choose industry over the agency. Simple things like a lack of computer and phone are a problem.
When it comes to the bigger issues such as dissenting opinions within the agency, specifically the nine employees who claimed publicly they were pressured to make approvals that were contrary to their professional opinion, or the 5 former employees who are suing the agency. There is no mention in the report how to handle dissenting opinions or the monitoring of employees while they are on the job.