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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.
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Drug Shortages: FDA's Ability to Respond Should Be Strengthened
http://www.gao.gov/products/GAO-12-116

GAO-12-116: Published: Nov 21, 2011. Publicly Released: Dec 15, 2011.

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