Key Issues > Medical Product Oversight
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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, Nov 21, 2011

Medical Devices

FDA Should Enhance Its Oversight of Recalls
GAO-11-468, Jun 14, 2011

Drug Safety

FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed
GAO-10-961, Sep 30, 2010

Food and Drug Administration

FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs
GAO-09-581, Jun 19, 2009

Medical Devices

FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
GAO-09-190, Jan 15, 2009

More Reports

National Preparedness

Improvements Needed for Measuring Awardee Performance in Meeting Medical and Public Health Preparedness Goals
GAO-13-278, Mar 22, 2013

Prevention and Public Health Fund

Activities Funded in Fiscal Years 2010 and 2011
GAO-12-788, Sep 13, 2012

Medical Devices

FDA Should Expand Its Consideration of Information Security for Certain Types of Devices
GAO-12-816, Aug 31, 2012

Prescription Drug Data

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

Medicare

Trends in Beneficiaries Served and Hospital Resources Used in Implantable Medical Device Procedures
GAO-12-583R, May 14, 2012

Food and Drug Administration

Employee Performance Standards for the Timely Review of Medical Product Applications
GAO-12-650R, Apr 18, 2012

Prescription Drugs

FDA Has Met Most Performance Goals for Reviewing Applications
GAO-12-500, Mar 30, 2012

Information Technology

FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks
GAO-12-346, Mar 15, 2012

Medical Devices

FDA Has Met Most Performance Goals but Device Reviews Are Taking Longer
GAO-12-418, Feb 29, 2012

Antibiotics

FDA Needs to Do More to Ensure That Drug Labels Contain Up-to-Date Information
GAO-12-218, Jan 31, 2012
More...

Videos

High Risk: Oversight of Medical Products

Podcasts

FDA Oversight of Medical DevicesWednesday, April 13, 2011