Contaminated Heart Pills Prompt Lawmakers to Question FDA Checks
(Bloomberg) -- Lawmakers on a powerful House committee have asked the U.S. Food and Drug Administration to answer questions about how contamination from a potentially cancer-causing chemical led to more than a dozen recalls of widely used cardiovascular drugs.
The House Energy and Commerce Committee on Wednesday wrote to FDA Commissioner Scott Gottlieb to ask about inspections of foreign drug plants that make the pills and that have been the subject of inspections that found shortcomings in quality controls.
Last month, a Bloomberg investigation found that FDA surveillance inspections of foreign and domestic drug manufacturing facilities had fallen in fiscal 2017 and fiscal 2018, even as the agency was approving record numbers of generic drugs. In some cases, including at a Chinese facility mentioned in the committee’s letter, FDA inspectors had raised red flags and recommended penalties only to be overruled by higher-ups at the agency.
The contaminated cardiovascular drugs, known as angiotensin II receptor blockers or ARBs, are mostly low-cost generic drugs used to treat high blood pressure. Millions of pills were subject to recall because of the contamination.
“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 members wrote in the letter. It was signed by Chairman Frank Pallone of New Jersey, ranking Republican Greg Walden of Oregon and other top Democratic and GOP members of the panel.
The FDA didn’t immediately respond to a request for comment. The agency has said that it has focused its overseas inspections on what it thinks are the highest-risk facilities.
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