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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 is encountering multiple challenges that threaten to compromise 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 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 (see figure). However, FDA still faces challenges that hamper its ability to respond to globalization. For example, there are persistently high vacancy rates in FDA’s foreign offices. Also, FDA has not meaningfully assessed the offices’ effectiveness.

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

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

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 recent years, the total number of shortages active during a given year—including both new shortages reported and ongoing shortages that began in a prior year—remain high (see figure).

Number of Drug Shortages from 2010 through 2015

Figure 1: Number of Active Drug Shortages from 2010 through 2015

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. The Drug Quality and Security Act, enacted in 2013, helped clarify FDA's authority to oversee drug compounding. FDA has taken steps to implement its regulatory responsibilities. However, states and stakeholder organizations, such as those representing pharmacies and pharmacists, identified challenges in FDA’s implementation of the law. For example, the amount of time FDA has taken to finalize the guidance and other documents has left stakeholder groups uncertain about how to move forward under the law. FDA also lacks reliable data to make decisions on how to prioritize its inspections of certain compounding pharmacies and other follow-up and enforcement actions.   

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” designations, 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 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.

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