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Bipartisan E&C Leaders Request GAO Review of FDA’s Foreign Drug Inspection Program

Jun 28, 2019
Press Release
Committee Leaders Request Additional Information Regarding FDA’s Resources, Policies, Management Practices, and Authorities Related to Oversight of Foreign Manufacturing

A bipartisan group of Energy and Commerce Committee leaders sent a letter to the Government Accountability Office (GAO) today requesting a review of the Food and Drug Administration’s (FDA) drug inspection program following a series of recent recalls of contaminated blood pressure medications that were manufactured in China and India.  The lawmakers also sent a letter to FDA following up on an earlier request for information on the agency’s ability to ensure the safety of the drug supply chain following a series of recalls involving drugs manufactured overseas. 

The letters were signed by Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Health Subcommittee Ranking Member Michael Burgess, M.D. (R-TX), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO), and Oversight and Investigations Ranking Member Brett Guthrie (R-KY).

“The Committee has long held an interest in FDA’s ability to oversee medical products manufactured overseas and in the foreign offices FDA set up to improve its oversight of these and other products,” the bipartisan Committee leaders wrote in their letter to GAO.  “Therefore, we request that GAO conduct a review of FDA’s drug inspection program.” 

In their request to GAO, the Committee leaders point to a recent Bloomberg investigation that analyzed FDA data and found a decline in foreign surveillance inspections at drug manufacturing establishments in 2017 and 2018.  Bloomberg’s review of FDA data and documents also suggested that FDA field inspection staff and managers at FDA’s Center for Drug Evaluation and Research (CDER) may differ on key concerns when violations are discovered during foreign drug inspections.

In their follow up letter to FDA, the Committee leaders requested additional information from FDA since the number of recalls of contaminated blood pressure medications continue to expand.  The lawmakers requested answers to their detailed list of questions by July 12, 2019. 

We remain concerned about whether FDA has the appropriate resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” the five bipartisan leaders wrote in their letter to FDA.

Since July 2018, there have been multiple recalls issued for a class of drugs known as angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure.  The series of recalls appear to be connected to at least two foreign drug manufacturing facilities: Zhejiang Huahai Pharmaceutical in China and Hetero Labs in India.  Both facilities had a history of troubling FDA inspection reports prior to the detection of trace amounts of carcinogens.

The Energy and Commerce Committee has long held an interest in FDA oversight of the manufacturing of finished drug products and active pharmaceutical ingredients intended for the U.S. drug supply.  In 2012, Congress passed legislation to give FDA the authority to inspect foreign and domestic firms on a risk-based schedule and allowed the agency to prioritize facilities that had not been subject to a recent inspection or that posed the highest risk.

Letter to GAO available HERE.

Letter to FDA available HERE.