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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:

  •  Drug shortages continue to remain a serious public health concern despite FDA’s efforts to prevent and mitigate drugs in short supply. Though new reports of drug shortages have declined in 2012, the total number of shortages active during a given year—including both new shortages reported and ongoing shortages that began in a prior year—has increased since 2007 (see figure 1).

Figure 1: Number of Active Drug Shortages from January 2007 through June 2013

GAO-12-116, Figure 1

  • Oversight of drug compounding—the process by which a pharmacist combines, mixes, or alters ingredients to create a drug tailored to the medical needs of an individual—became a serious concern in 2012.  An outbreak of fungal meningitis linked to contaminated compounded drugs, resulted in over 60 deaths and hundreds of people becoming ill.
  • Most rogue internet pharmacies operate from abroad, and many illegally ship prescription
    drugs in the United States that have not been approved by FDA. The complex and global nature of rogue Internet pharmacies poses substantial challenges for federal investigators and prosecutors (see figure 2).

Figure 2: : Map of a Rogue Internet Pharmacy Operation

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, and
  • enhance postmarket safety.
Looking for our recommendations? Click on any report to find each associated recommendation and its current implementation status.

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.

Drug Compounding:

Clear Authority and More Reliable Data Needed to Strengthen FDA Oversight
GAO-13-702:
Published: Jul 31, 2013. Publicly Released: Jul 31, 2013.

Internet Pharmacies:

Federal Agencies and States Face Challenges Combating Rogue Sites, Particularly Those Abroad
GAO-13-560:
Published: Jul 8, 2013. Publicly Released: Jul 8, 2013.

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.

Drug Shortages:

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

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.

Medicaid Prescription Drugs:

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.

Prescription Drugs:

FDA Has Met Most Performance Goals for Reviewing Applications
GAO-12-500:
Published: Mar 30, 2012. Publicly Released: Apr 30, 2012.

Information Technology:

FDA Needs to Fully Implement Key Management Practices to Lessen Modernization Risks
GAO-12-346:
Published: Mar 15, 2012. Publicly Released: Apr 16, 2012.
More...

Videos

High Risk: Oversight of Medical Products
AskGAOLive Chat on Prescription Drug Shortages
AskGAOLive Chat on Internet Pharmacies