Key Issues > Medical Product Oversight - High Risk Issue
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Medical Product Oversight - High Risk Issue

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 faces multiple challenges that threaten its ability to protect public health. These challenges make medical product oversight a high risk issue and include:

Globalization
The United States has become increasingly dependent on global markets to supply its drugs and medical devices. According to the Food and Drug Administration (FDA), nearly 40 percent of the finished drugs and about 50 percent of the medical devices used in the United States are made overseas, which has complicated FDA’s efforts to assess the quality of these medical products.

FDA has attempted to respond to this through a variety of activities, such as by increasing the number of foreign establishments it inspects each year. However, the agency could do more, such as develop performance measures for, and meaningfully assess the effectiveness of, its foreign offices.

Food and Drug Administration (FDA) Inspections of Domestic and Foreign Drug Establishments, Fiscal Year 2007 through June 30, 2016

Food and Drug Administration (FDA) Inspections of Domestic and Foreign Drug Establishments, Fiscal Year 2007 through June 30, 2016

Drug shortages

Drug shortages continue to be a serious public health concern, despite FDA's efforts to prevent and mitigate supply issues. Though new reports of drug shortages have declined in recent years, the total number of shortages during any given year—including both new shortages and ongoing shortages that began in a prior year—remains high. Although FDA alone cannot guarantee drug availability, the agency needs to conduct periodic analyses to assess drug shortage information and identify risk factors for potential drug shortages.

Drug Shortages, 2010- 2015

Drug Shortages, 2010- 2015

Drug safety monitoring
FDA may use expedited programs, such as “fast track” or “breakthrough therapy” designations, to bring drugs to market more quickly to treat serious or life-threatening conditions. These expedited programs sometimes allow drugs to be approved based on fewer or smaller clinical trials.

FDA conducts ongoing safety monitoring for all the drugs it approves after they go to market. However, the agency lacks reliable, readily accessible data to support this type of systematic oversight. Consequently, it cannot fully determine whether expedited drugs have different safety issues once they are more widely used than nonexpedited drugs.

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