E&C Leaders Seek FDA Briefing on Contaminated Sartans

Regulatory NewsRegulatory News
| 13 February 2019 | By Ana Mulero 

A bipartisan group of lawmakers who serve on the US House Committee on Energy and Commerce (E&C) sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday to request a briefing on the sartan safety issues that prompted a string of recalls worldwide.

“Beginning in July 2018, there have been at least 15 recalls issued for a variety of angiotensin II receptor blockers (ARB), which are generally used to treat high blood pressure,” the E&C committee members noted. “The roots of this ever-expanding series of recalls appear to be related to at least two foreign drug manufacturing facilities: Zhejiang Huahai Pharmaceutical (ZHP) in China and Hetero Labs in India.”

In addition to the noted facilities, low levels of the detected impurities have also been linked to a second China-based company and a second India-based company: Zhejiang Tianyu and Aurobindo Pharma, respectively. The ARBs, which include valsartan, losartan, irbesartan, candesartan and olmesartan, were manufactured in bulk and distributed globally, and the two impurities that had been classified as probable human carcinogens went unaddressed by regulators until mid-2018. This is despite Form 483s to ZHP that indicated FDA became aware of quality defects years prior.

The impurities—known as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA)—have so far only been detected in three out of the five sartans. Valsartan, losartan and irbersartan products have been subject to recalls issued by FDA, though the scandal began with a Europe-wide valsartan recall last July.
Now, the E&C members want FDA to brief committee staff on the agency’s response to the issue.

The E&C members cited a 2016 report from the Government Accountability Office and a January 2019 analysis conducted by Kaiser Health News as grounds to call for the briefing. The research highlighted FDA’s increased inspections of foreign drug manufacturing facilities, but the agency’s backlog of uninspected foreign drug facilities remains. “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 E&C committee members wrote. Signatories include E&C chairman Rep. Frank Pallone (D-NJ) and chairwoman of the health subcommittee Rep. Anna Eshoo (D-CA), as well as four other members.

The letter comes after FDA officials, including Gottlieb, issued a statement last month to inform of the agency’s work to address the root causes of the sartan safety issues. It also follows on the heels of the outcome of the sartan review conducted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, which was posted earlier this month. Both FDA and EMA have found that the sartan safety scandal stemmed from poor quality controls in drug manufacturing procedures.



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