Regulatory Focus™ > News Articles > GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

Posted 16 February 2017 | By Michael Mezher 

GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday.

Despite commitment from FDA leadership to improve drug availability, GAO says it no longer considers FDA's action plan to be effective.

As a result, GAO has downgraded its assessment of FDA's action plan from meeting its expectations in 2015 to only partially meeting them. FDA's downgrade in this regard is one of only two downgrades in GAO's nearly 700 page report.

"We have identified several concerns with the agency's readiness and plans to collect, track, and analyze data related to drug shortages and postmarket drug safety. We have also reported on shortcomings in its broader strategic planning efforts related to drugs and other medical products," GAO writes.

Foreign Oversight

When it comes to FDA's response to globalization, including the agency's oversight of foreign manufacturers, GAO's evaluation of FDA remains unchanged from 2015.

While GAO says that FDA leadership's commitment and action plan for improving foreign oversight meets its expectations, FDA's capacity to effectively oversee foreign manufacturers and the agency's own internal monitoring of its foreign operations remain a challenge.

Specifically, GAO references a report it released in January that found FDA struggled to staff its foreign offices and does not "systematically track" their foreign activities.

"FDA still faces challenges overseeing the global marketplace and must continue to demonstrate progress in conducting more inspections of foreign establishments. There remains a large number of foreign establishments making drugs for the US market—almost 1,000—that may never have been inspected," GAO writes.


The report, which comes every two years, evaluates the level of risk posed by federal programs based on five criteria: leadership commitment, action plan, capacity, monitoring and demonstrated progress.

Since 2009, various FDA programs have been included on in the report due to challenges the agency faces in ensuring public health and safety.

"Rapid changes in science and technology, globalization, unpredictable public health crises, an increased workload, and the continuing need to monitor the safety of thousands of marketed medical products are among the many challenges with which FDA must routinely contend," GAO writes.

Medical Devices

Since the last report in 2015, GAO says FDA has "significantly improved its oversight of medical device recalls and the implementation of the Safe Medical Devices Act of 1990," prompting GAO to remove those as high-risk areas for the agency.

"FDA met all five criteria … for having the high-risk designation removed for both medical device areas," GAO writes.


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