Ensuring Medical Product Safety

FDA is responsible for overseeing the safety and effectiveness of human drugs and medical devices that are marketed in the United States, whether they are manufactured in domestic or foreign establishments.

• Although FDA is implementing initiatives to improve oversight, weaknesses in the agency's monitoring and enforcement process hamper its ability to effectively oversee postmarketing studies.

  Highlights of GAO-09-866

• Inspections of manufacturing establishments are an essential component of ensuring safety, FDA conducts relatively few foreign establishment inspections — despite U.S. dependence on drugs and medical devices from overseas.

  Highlights of GAO-08-970 (PDF), Highlights of GAO-08-780T (PDF)

• FDA's management of its foreign inspection programs has been compromised by weaknesses in its data systems, which contain conflicting information, and thus complicate FDA's ability to appropriately prioritize foreign establishments for inspection.

  Highlights of GAO-08-970 (PDF), Highlights of GAO-08-780T (PDF)

• FDA is further challenged by circumstances unique to inspections of foreign establishments, such as a lack of translators.

  Highlights of GAO-08-970 (PDF), Highlights of GAO-08-780T (PDF)

• Although FDA has proposed initiatives to improve foreign inspections, it is too early to tell whether they will be effective.

  Highlights of GAO-08-970 (PDF), Highlights of GAO-08-780T (PDF)

• In addition to these inspection issues, FDA has not issued regulations to ensure that high-risk types of medical devices are approved through the most stringent premarket review process.

  Highlights of GAO-09-190 (PDF)

• FDA has used medical device recall data to monitor individual recalls and target firms for inspections, but has not routinely analyzed the data to determine whether there are systemic problems underlying trends in device recalls.

  Highlights of GAO-11-468 (PDF)

• FDA’s procedures for overseeing device recalls are unclear and the agency has not established criteria for assessing whether firms corrected or removed a sufficient number of recalled devices.

  Highlights of GAO-11-468 (PDF)

• Further, FDA did not maintain sufficient documentation to support its justifications for terminating device recalls, making it uncertain whether FDA had appropriately assessed firms’ efforts to prevent a recurrence of the problems that led to the recalls.

  Highlights of GAO-11-468 (PDF)

• Additionally, while the reauthorization of the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) have had success in encouraging studies of drug and biological products for use in children, the FDA does not have procedures in place track and aggregate data about applications subject to PREA. As a result, FDA is unable to track how long it has had a drug application or whether the application includes information from pediatric studies, which could delay the dissemination of important pediatric study results.

  Highlights of GAO-11-457 (PDF)

• FDA is beginning to address previously identified weaknesses in its oversight of postmarket drug safety. However, challenges remain, including the timely transfer of responsibilities to different organizational components and meeting an expanding workload.

  Highlights of GAO-10-68 (PDF)

• Although FDA officials acknowledged challenges in its ability to fulfill and manage its growing medical product oversight responsibilities that it attributed to resource constraints, the agency could not provide the information necessary to develop reliable estimates of its resource needs.

  Highlights of GAO-09-581 (PDF)

• FDA is constrained in its ability to protect public health from drug shortages due to its lack of authority to require manufacturers to take certain actions to prevent, alleviate, or resolve shortages. The agency is also constrained due to management challenges, such as not systematically maintaining data on drug shortages, without which it is unable to monitor trends and enhance its ability to address the causes of drug shortages.

  Highlights GAO-12-116 (PDF)

• FDA's authority for debarring and disqualifying investigators who engage in scientific misconduct is limited and we found debarment and disqualification proceedings that were delayed, with a few proceedings taking more than a decade. Delays in the timely completion of the agency's debarment and disqualification proceedings were due in part to internal control weaknesses, such as a lack of established time frames for completion of the proceedings.

  Highlights of GAO-09-807 (PDF)

^ Back to topWhat Needs to Be Done

FDA should

• clarify the conditions under which it would utilize its authority to expedite the withdrawal of drugs under its accelerated approval process;

  Highlights of GAO-09-866 (PDF)

• improve the data that it uses to manage its foreign inspection program, conduct more inspections of foreign establishments, and ensure more timely inspection of foreign establishments where FDA has identified serious deficiencies;

  Highlights of GAO-08-970 (PDF)

• improve its processes for identifying and reviewing final and draft direct-to-consumer advertising materials;

  Highlights of GAO-07-54 (PDF)

• improve the postmarket drug safety decision-making process;

  Highlights of GAO-06-402 (PDF)

• develop a comprehensive plan to prepare its Office of Surveillance and Epidemiology for the transfer of additional regulatory authorities from the Office of New Drugs;

  Highlights of GAO-10-68 (PDF)

• take steps to expeditiously issue regulations for class III medical devices, which represent the greatest risk to patients, requiring that these devices obtain premarket approval or be reclassified to a lower class;

  Full Report of GAO-09-190 (PDF, 35 pages)

• routinely assess information on device recalls, develop enhanced procedures and criteria for assessing the effectiveness of recalls, and document the agency’s basis for terminating individual recalls;

  Highlights of GAO-11-468 (PDF)

• track applications during its review process and maintain aggregate data on applications subject to PREA;

  Highlights of GAO-11-457 (PDF)

• establish a comprehensive and reliable basis for substantiating the agency's resource needs;

  Full Report of GAO-09-581 (PDF)

• take steps to enhance the agency’s ability to respond to drug shortages, for example, by developing an information system to manage data about shortages;

  Highlights of GAO-12-116 (PDF)

• pursue extending the agency's debarment authority; extend disqualification to include drugs, biologics, and medical devices; and ensure timely completion of debarment and disqualification proceedings.

  Full Report of GAO-09-807 (PDF)

In addition, Congress should consider establishing a requirement for manufacturers to report current or potential supply disruptions to FDA.

Highlights of GAO-12-116 (PDF)

^ Back to topKey Reports

Pediatric Research

Oversight of Clinical Investigators

New Drug Approval

Medical Devices

Medical Devices

Medical Devices

Medical Devices

Food and Drug Administration

Federal Courthouse Construction

Drug Shortages

Drug Safety

Drug Safety

Drug Safety

More Reports