GAO wants US FDA to show benefits of overseas inspections

By Gareth Macdonald contact

- Last updated on GMT

iStock/ake1150sb
iStock/ake1150sb

Related tags: Fda, Pharmaceutical drug, Government accountability office

The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.

Despite President elect Donald Trump’s recent​ claim to the contrary, most drugs​ used in the US are made at US facilities.

According to the Department of Commerce​ around $86bn (€80bn) of the $333bn worth of finished drugs used in the US each year are imported.

Nevertheless, many non-US facilities are involved in the US pharmaceutical supply chain, particularly if you include active pharmaceutical ingredients (API) 80% of which are imported according to the US Food and Drug Administration (FDA)​.

Overseas oversight

This was flagged in a new US Government Accountability Office (GAO) report​ which acknowledged the FDA’s efforts to increase the number of overseas manufacturing facilities it inspects.

The GAO said: “The number of foreign inspections has consistently increased each year since fiscal year 2009. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspections.

FDA has also improved the accuracy and completeness of information on its catalog of drug establishments subject to inspection. It has also reduced its catalog of drug establishments with no inspection history to 33 percent of foreign establishments, compared to 64 percent in 2010​.”

Foreign offices

However, while it recognized the increase in foreign inspections, the GAO voiced concerns about the impact of the FDA’s efforts and the lack of feedback being provided by its overseas offices.

FDA has not yet assessed its foreign offices’ contributions to drug safety. FDA has made progress in its strategic planning for its offices in China, Europe, India, and Latin America, but the lack of an assessment is inconsistent with federal standards for internal controls​.”

The GAO’s main concern focused on metrics the FDA uses to assess performance —the number of medical product inspections and number of collaborative actions— which is suggested “does not capture the offices’ unique contributions to drug safety.”

It also raised an flag about the difficulty the agency has had in recruiting investigators, pointing out that in July 2016 46 percent of the foreign offices’ authorized positions were vacant.

Although FDA recently finalized a workforce plan, GAO identified several weaknesses with it. For example, the plan sets a workforce target that applies to both foreign and domestic international program offices, making it difficult to ascertain whether its goal of reducing foreign office staff vacancies is being met​.”

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