Tainted Drugs Used by Millions Stir Alarm in Congress About FDA
(Bloomberg) -- Lawmakers from both parties are seeking more information about regulators’ capacity to protect the U.S. drug supply, as foreign-made generic blood-pressure pills tainted with probable carcinogens continue to be recalled.
House Energy and Commerce Committee Chairman Frank Pallone, a New Jersey Democrat, and Oregon Representative Greg Walden, the panel’s top Republican, want details on the U.S. Food and Drug Administration’s ability to adequately inspect foreign and domestic pharmaceutical manufacturing facilities, according to documents provided to Bloomberg.
The lawmakers are seeking specific information regarding a recall of the drug valsartan that was manufactured by Chinese firm Zhejiang Huahai Pharmaceutical Co. Ltd. They also want more details about a dispute between senior FDA staff and an inspector who visited one of the company’s plants where medication contaminated with the probable human carcinogen NDMA was first detected.
The FDA began a recall of valsartan made by Zhejiang Huahai in July 2018. The company’s contaminated valsartan was sold to major drugmakers and used as an ingredient in a number of popular cardiovascular therapies. Since then, the FDA has found that other pharmaceutical companies, including Mylan NV and India’s Hetero Labs Ltd., made and sold contaminated blood-pressure drugs. The recalls have sparked a wave of lawsuits.
In a letter to the Government Accountability Office on Friday, Pallone, Walden and other committee leaders asked the investigator to examine the number of inspections that the FDA conducts of foreign and domestic drug-manufacturing facilities, what resources the agency dedicates to its foreign offices, and how it chooses facilities to inspect.
In a separate letter, the committee leaders asked the FDA for unredacted documents related to the initial valsartan recall, including a memo first reported by Bloomberg News in which senior FDA officials in the U.S. overrode concerns raised by an inspector who had visited Zhejiang Huahai in May 2017, a little over a year before the recall began.
The letter to the GAO cites a Bloomberg News investigation earlier this year that found that surveillance inspections by the FDA were down. The report also detailed efforts by generic-drug and ingredient makers, including Zhejiang Huahai, to manipulate data and ignore signs that their products didn’t meet U.S. standards.
“Bloomberg’s review of FDA data and documents also suggested the 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,” the committee leaders wrote.
The panel had asked for an FDA briefing on its inspections as well as the recall in February. The letter to the agency on Friday noted the briefing had occurred but that its document request went beyond that.
“We remain concerned about whether FDA has the appropriate resources, policies, management practices, and authorities to oversee adequately foreign drug manufacturing,” lawmakers wrote FDA Acting Commissioner Ned Sharpless.
The Energy and Commerce Committee has previously probed the FDA’s ability to police the drug supply. The panel investigated and held hearings after a 2008 crisis in which a contaminated blood thinner called heparin made in China was linked to more than 200 deaths in the U.S. Lawmakers used a 2012 law to boost the FDA’s ability to inspect foreign drugmakers.
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