GAO Dings FDA Inspections, Capabilities
The General Accountability Office (GAO) released a report (pdf) at the end of January which evaluated challenges faced by the FDA in conducting manufacturer inspections to ensure safety of medical devices. The report assessed ongoing inspections, especially those on foreign soil, as well as the agencies certified to conduct such. To complete the report, officials from the FDA’s Office of Regulatory Affairs (ORA) and Center for Devices and Radiological Health (CDRH) were interviewed.
The GAO notes the significant onus placed on the FDA to inspect both domestic and foreign manufacturing facilities. The Medical Drug User Fee and Modernization 0f 2002 was passed, in part, to expand the ability of the regulatory agency to fulfill this requirement. That allowed for the establishment of third party organizations accredited to conduct inspections. However, limited agencies have been approved and inspections continue to lag. The FDA subcommittee on science and technology previously noted that there are notable weaknesses across the entire agency.
The report commences by noting that the FDA has failed to fulfill its obligations to inspect manufacturers every other year, especially those agencies which are overseas. There have yet to be review requirements, however, established for manufacturers not on U.S. soil. Importantly, devices that are Class II or III are being assessed, just not within the specified time frame.
Additional concerns have arisen about the agency’s ability to assess the safety and manufacturing of pharmaceutical products, in addition to the issues faced regarding medical devices already described. So, too, did the GAO report limited inspections in this arena. Other issues noted include weaknesses in the FDA data systems, such as conflicting information. Particular issues for foreign inspections were brought to light in the report, such as the extent of human resources available to conduct inspections.
One concern included in the report is that the increasing responsibilities of the FDA cannot be met with the current budgeting for the agency, which has also been noted in a report issued by the Science Board of the FDA. The agency is being held responsible for increasingly international considerations. The GAO reports notes a significant gap between the responsibilities assigned to the FDA and the resources to fulfill such. The consequence of such is a failure to fulfill all obligations.
An additional concern noted is the outdated information technology system employed by the FDA. That system is currently not adequate to support access, integration, and analysis of data. A further complication is that the system often fails. This system has been particularly troublesome in managing evaluation of foreign entities.
An editorial piece was posted in the British Medical Journal noting some of these same concerns about FDA capabilities to ensure oversight effectively, based on the recent GAO report. As well, President Bush’s recently proposed FDA funding for fiscal year 2009 has brought to light concerns about the disparity between funding, capabilities, and overall responsibilities which was detailed on HospitalBuyer.
February 14, 2008 Related topics: Trends, Quality, Safety, Errors