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Medical Product Oversight

Americans depend on the Food and Drug Administration (FDA) to oversee the safety and effectiveness of medical products—drugs, biologics, and medical devices. FDA’s medical product responsibilities are far-reaching and demands on the agency have soared in recent years.

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FDA is encountering multiple challenges that threaten to compromise its ability to protect public health, including:

  • FDA has a limited ability to respond to critical shortages of prescription drugs. From 2006 through 2010, the number of shortages increased dramatically and a record number (196) were reported in 2010.

Figure 1: Number of Drug Shortages Reported January 1, 2001, through June 20, 2011, by Year

GAO-12-116, Figure 1

  • Medical device recalls were often prolonged. FDA did not complete timely assessments of whether firms had taken sufficient actions to prevent problems from recurring for more than 70 percent of the highest risk, or class I, recalls initiated in 2005 through 2009. (See figure 2.)

Figure 2: Percentage of Medical Device Recalls Terminated More than 90 Days after Completion Date, for Recalls Initiated in Calendar Years 2005 through 2009

GAO-11-468, Figure 5

  • FDA conducts relatively few foreign drug inspections and many foreign drug establishments may never have been inspected. (See table 1.)

Table 1: Numbers of Establishments in FDA’s Inventory That May Never Have Been Inspected by FDA and the Total Estimated Number of Establishments in Its Inventory, by Country, Fiscal Year 2009

GAO-10-961, Table 2

FDA has many challenges to address, including the need to:

  • respond to globalization,
  • react quickly to public health needs,
  • enhance postmarket safety, and
  • improve planning and resource management.
Looking for our recommendations? Click on any report to find each associated recommendation and its current implementation status.

Drug Shortages:

FDA's Ability to Respond Should Be Strengthened
GAO-12-116:
Published: Nov 21, 2011. Publicly Released: Dec 15, 2011.

Medical Devices:

FDA Should Enhance Its Oversight of Recalls
GAO-11-468:
Published: Jun 14, 2011. Publicly Released: Jun 21, 2011.

Drug Safety:

Food and Drug Administration:

Medical Devices:

More Reports

Drug Shortages:

Threat to Public Health Persists, Despite Actions to Help Maintain Product Availability
GAO-14-339T:
Published: Feb 10, 2014. Publicly Released: Feb 10, 2014.

Drug Shortages:

Public Health Threat Continues, Despite Efforts to Help Ensure Product Availability
GAO-14-194:
Published: Feb 10, 2014. Publicly Released: Feb 10, 2014.

Medicaid Prescription Drugs:

Electronic Drug Labeling:

No Consensus on the Advantages and Disadvantages of Its Exclusive Use
GAO-13-592:
Published: Jul 8, 2013. Publicly Released: Jul 8, 2013.

National Preparedness:

Prevention and Public Health Fund:

Activities Funded in Fiscal Years 2010 and 2011
GAO-12-788:
Published: Sep 13, 2012. Publicly Released: Oct 15, 2012.

Medical Devices:

FDA Should Expand Its Consideration of Information Security for Certain Types of Devices
GAO-12-816:
Published: Aug 31, 2012. Publicly Released: Sep 27, 2012.

Prescription Drug Data:

HHS Has Issued Health Privacy and Security Regulations but Needs to Improve Guidance and Oversight
GAO-12-605:
Published: Jun 22, 2012. Publicly Released: Jun 22, 2012.

Medicare:

Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures
GAO-12-583R:
Published: May 14, 2012. Publicly Released: Jun 13, 2012.

Food and Drug Administration:

Employee Performance Standards for the Timely Review of Medical Product Applications
GAO-12-650R:
Published: Apr 18, 2012. Publicly Released: May 18, 2012.
More...

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High Risk: Oversight of Medical Products