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E&C Leaders Request FDA Briefing on Contaminated Drugs and Agency’s Foreign Drug Inspections

Feb 13, 2019
Press Release
Leaders Voice Concern About At Least 15 Recalls Since July 2018 of Drugs Made Overseas Used Generally to Treat High Blood Pressure

Bipartisan Energy and Commerce leaders sent a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb today requesting a briefing on a series of recalls that appear to involve drugs manufactured overseas that may have been contaminated with trace amounts of known carcinogens, which could lead to a shortage of drugs to treat high blood pressure.

The letter was signed by Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), 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).

Since July 2018, there have been at least 15 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.

“Given our concerns in this area, we are requesting that FDA provide Committee staff with a briefing on the basis and impact of ARB recalls as well as a briefing on FDA’s efforts to conduct foreign inspections and what ongoing challenges currently exist for the agency,” the Committee leaders wrote to FDA.

The Energy and Commerce Committee has long held an interest in FDA’s ability to oversee 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.

The letter to FDA is available HERE.