Protecting Public Health through Enhanced Oversight of Medical Products

Why It's High Risk

Oversight of Medical Products

The Food and Drug Administration (FDA) oversees the safety and effectiveness of all medical products marketed in the United States, regardless of whether they are manufactured here or abroad. Globalization has placed increasing demands on the agency. For example, drugs manufactured in more than 100 countries were offered for entry into the United States in fiscal year 2009. The oversight of medical products was added to GAO's High-Risk List in January 2009 because FDA was facing multiple challenges that threatened to compromise its ability to protect the public health. GAO identified weaknesses in several areas, including inspections of foreign manufacturing establishments, postmarket safety monitoring, and oversight of clinical trials. FDA will need to respond to these challenges, in addition to managing a growing workload.

^ Back to topWhat We Found

In our work, we found:

• Resource management and strategic planning. FDA has encountered difficulties in fulfilling its growing medical product responsibilities and does not have reliable estimates of its resource requirements or data showing its workload and accomplishments in some areas.
• Performance measures. FDA's performance measures are only partially results-oriented and do not clearly focus on results, such as public health outcomes, the agency's strategic objectives, and identified management challenges. FDA also does not have an agencywide strategic human capital plan.
• Globalization. While FDA's recently established overseas offices are engaging in activities to help ensure the safety of imported products, FDA has not yet developed a long-term workforce plan that could help address the offices' potential staffing challenges. FDA also lacks a set of performance goals and measures that can demonstrate the contribution of these offices to the long-term outcomes related to the regulation of imported products.
• Conducting foreign drug inspections. Although FDA also increased its inspections of foreign drug establishments, it still conducts relatively fewer foreign inspections than it conducts domestically. Further, FDA's approach in selecting establishments for inspection is inconsistent with GAO's 2008 recommendation that FDA inspect, at a comparable rate, those establishments that are identified as having the greatest public health risk potential, if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment.
• Managing data on foreign drug establishments. FDA's data systems which are used to manage its foreign drug inspection program continue to contain inaccurate information on foreign establishments, compromising the agency's oversight. Although the agency has begun to initiate some improvements, these efforts are in the early stages.
• Postmarket Safety. Long-standing concerns remain regarding the effectiveness of FDA's postmarket oversight. FDA staff have expressed concern about their ability to meet a growing postmarket workload, with some maintaining that their premarket responsibilities are considered a higher priority. FDA is also encountering technological and staffing issues that limit its capacity to conduct drug safety studies.
• Implementing the Safe Medical Devices Act of 1990. A significant number of high-risk medical devices still enter the market through FDA's less stringent premarket approval process, despite requirements contained in the act that FDA either reclassify certain high-risk medical device types to a less-risky class or establish a schedule for such devices to be approved through its most stringent premarket approval process.

^ Back to topWhat Needs to Be Done

FDA should take actions to improve its oversight of medical products and thus enhance public health. Such actions include:

• Strengthening its resource management and its strategic and human capital planning. To ensure it has the capacity to fulfill its mission, it must establish reliable estimates of resource needs and use these estimates in planning and prioritizing its work.
  GAO-09-581   GAO-10-226   GAO-10-279
• Developing more results-oriented performance measures—particularly in light of increasing demands facing the agency.
  GAO-10-279
• Conducting more inspections of foreign drug establishments and inspecting those foreign establishments that pose a greater public health risk at a frequency comparable to domestic establishments with similar characteristics and continue to improve the information it uses to manage the foreign drug inspection program.
  GAO-10-961
• Creating a workforce plan for its new overseas offices and acknowledging that it may need new legal authorities to better oversee foreign establishments.
  GAO-10-960
• Balancing the demands of globalization with its other priorities, such as implementing a rigorous postmarket safety system without sacrificing a thorough and careful premarket approval process. FDA also needs to place additional emphasis on ensuring staff can fulfill their postmarket duties and the careful monitoring of postmarket studies.
  GAO-10-68   GAO-10-866
• Establishing a plan and a timetable for ensuring that high-risk medical device types are approved through FDA's most stringent premarket approval process.
  GAO-10-190

^ Back to topKey Reports

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