Government
Gao: FDA has more work to do to secure food, medical device
By GAO
Jan 30, 2008 - 4:14:24 AM

Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical

GAO-08-435T  January 29, 2008

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The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. The recent outbreaks of E. coli in spinach, Salmonella in peanut butter, and contamination in pet food highlight the risks posed by the accidental contamination of FDA-regulated food products. Changing demographics and consumption patterns underscore the urgency for effective food safety oversight. In response to these challenges, in November 2007, FDA and others released plans that discuss the oversight of food safety. FDA's Food Protection Plan sets a framework for food safety oversight. In addition, FDA's Science Board released FDA Science and Mission at Risk, which concluded that FDA does not have the capacity to ensure the safety of the nation's food supply. This testimony focuses on (1) federal oversight of food safety as a high-risk area that needs a governmentwide reexamination, (2) FDA's opportunities to better leverage its resources, (3) FDA's Food Protection Plan, and (4) tools that can help agencies to address management challenges. To address these issues, GAO interviewed FDA officials; evaluated the Food Protection Plan using a GAO guide for assessing agencies' performance plans; and reviewed pertinent statutes and reports. GAO also analyzed data on FDA inspections and resources.

FDA is one of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in January 2007 and called for a governmentwide reexamination of the food safety system. We have reported on problems with this system--including inconsistent oversight, ineffective coordination, and inefficient use of resources. FDA has opportunities to better leverage its resources. Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace. GAO has recommended that FDA establish equivalence agreements with other countries to shift some oversight responsibility to foreign governments, explore the potential for certifying third party inspections, and consider accrediting private laboratories to inspect seafood, among other actions. We also reported that FDA and the U.S. Department of Agriculture (USDA) conduct similar inspections at 1,451 facilities that produce foods regulated by both agencies. To reduce overlaps, we recommended that, if cost-effective, FDA enter into an agreement to commission USDA inspectors at such facilities. FDA incorporated some of these recommendations in its Food Protection Plan. FDA's Food Protection Plan also proposes some positive first steps intended to enhance its oversight of food safety. Specifically, FDA requests authority to order food safety recalls and issue additional preventive controls for high-risk foods, both of which GAO has previously recommended. However, more specific information about its strategies and the resources FDA needs to implement the plan would facilitate congressional oversight. FDA officials acknowledge that implementing the Food Protection Plan will require additional resources. Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan's success in achieving its intended results. The Science Board cites numerous management challenges that have contributed to FDA's inability to fulfill its mission, including a lack of a coherent structure and vision, insufficient capacity in risk assessment, and inadequate human capital recruitment and retention. In light of these challenges, GAO has identified through other work some tools that can help agencies improve their performance over time. For example, a Chief Operating Officer/Chief Management Officer can help an agency address longstanding management problems that are undermining its ability to accomplish its mission and achieve results. In addition, a well-designed commission can produce specific practical recommendations that Congress can enact. Critical success factors that can help ensure a commission's success include a statutory basis with adequate authority, a clear purpose and timeframe, leadership support, an open process, a balanced membership, accountability, and resources.

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Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections

GAO-08-428T  January 29, 2008

Highlights Page (PDF)   Full Report (PDF, 26 pages)   

As part of the Food and Drug Administration's (FDA) oversight of the safety and effectiveness of medical devices marketed in the United States, it inspects domestic and foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. GAO previously reported on the status of one of these programs, citing concerns regarding its implementation and factors that may influence manufacturers' participation. (Medical Devices: Status of FDA's Program for Inspections by Accredited Organizations, GAO-07-157, January 2007.) This statement (1) assesses FDA's management of inspections of establishments--particularly those in foreign countries--manufacturing devices for the U.S. market, and (2) provides the status of FDA's programs for third-party inspections of medical device manufacturing establishments. GAO interviewed FDA officials; reviewed pertinent statutes, regulations, guidance, and reports; and analyzed information from FDA databases. GAO also updated its previous work on FDA's programs for inspections by accredited third parties.

FDA has not met the statutory requirement to inspect certain domestic establishments manufacturing medical devices every 2 years, and the agency faces challenges inspecting foreign establishments. FDA primarily inspected establishments located in the United States. The agency has not met the biennial inspection requirement for domestic establishments manufacturing medical devices that FDA has classified as high risk, such as pacemakers, or medium risk, such as hearing aids. FDA officials estimated that the agency has inspected these establishments every 3 years (for high risk devices) or 5 years (for medium risk devices). There is no comparable requirement to inspect foreign establishments, and agency officials estimate that these establishments have been inspected every 6 years (for high risk devices) or 27 years (for medium risk devices). FDA faces challenges in managing its inspections of foreign medical device establishments. Two databases that provide FDA with information about foreign medical device establishments and the products they manufacture for the U.S. market contain inaccuracies that create disparate estimates of establishments subject to FDA inspection. Although comparing information from these two databases could help FDA determine the number of foreign establishments marketing medical devices in the United States, these databases cannot exchange information and any comparisons must be done manually. Finally, inspections of foreign medical device manufacturing establishments pose unique challenges to FDA in human resources and logistics. Few inspections of medical device manufacturing establishments have been conducted through FDA's two accredited third-party inspection programs--the Accredited Persons Inspection Program and the Pilot Multi-purpose Audit Program (PMAP). From March 11, 2004--the date when FDA first cleared an accredited organization to conduct independent inspections--through January 11, 2008, five inspections have been conducted by accredited organizations through FDA's Accredited Persons Inspection Program. An incentive to participation in the program is the opportunity to reduce the number of inspections conducted to meet FDA and other countries' requirements. Disincentives include bearing the cost for the inspection, particularly when the consequences of an inspection that otherwise might not occur in the near future could involve regulatory action. The Food and Drug Administration Amendments Act of 2007 made several changes to program eligibility requirements that could result in increased participation by manufacturers. PMAP was established on September 7, 2006, and as of January 11, 2008, two inspections had been conducted by an accredited organization through this program, which is more limited than the Accredited Persons Inspection Program. The small number of inspections completed to date by accredited third-party organizations raises questions about the practicality and effectiveness of establishing similar programs that rely on third parties to quickly help FDA fulfill its responsibilities.

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