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The oversight of medical products was added to our High Risk List in 2009 because FDA is encountering multiple challenges that threaten to compromise its ability to protect public health, including:

Postmarket safety - When there is an unmet need for the treatment of a serious condition, FDA may use one or more of its expedited programs, such as fast track and breakthrough therapy designation, which are intended to bring drugs to market more quickly and may allow for approval based on fewer or smaller clinical trials. After approval, FDA is responsible for ongoing safety monitoring for both expedited and nonexpedited drugs and must report on certain postmarket safety efforts. However, FDA lacks reliable, readily accessible data to support systematic postmarket oversight and reporting and has not examined the postmarket data it collects to determine whether expedited drugs differ in the types of safety issues that arise once these drugs are more widely used.

Drug availability –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

(Excerpted from GAO-14-194)

Drug compounding –Pharmaceutical compounding, the process by which a pharmacist combines, mixes, or alters ingredients to create a drug tailored to the medical needs of an individual, is an integral part of the pharmacy profession. However, compounded drugs can pose special risks if made improperly. Compounding became a serious concern in 2012 when an outbreak of fungal meningitis linked to contaminated compounded drugs, resulted in over 60 deaths and hundreds of people becoming ill.

Globalization – The United States has become increasingly dependent on global markets to supply the drugs and devices used daily. According to FDA, nearly 40 percent of finished drugs and about 50 percent of all medical devices are made overseas. The rapid pace and magnitude of globalization has complicated FDA’s efforts to ensure that the medical products we need are of high quality. FDA has engaged in a variety of activities to respond, such as increasing the number of foreign establishments it inspects each year, but challenges remain.

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