Drugs

Hill Seeks FDA Briefing on Blood Pressure Drug Recalls

House Energy and Commerce Committee leaders have sent a letter to FDA commissioner Scott Gottlieb requesting a briefing on numerous recalls involving 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 (see earlier story). The letter was signed by chairman Frank Pallone, Jr. (D-NJ) and ranking member Greg Walden (R-OR); Health subcommittee chairwoman Anna G. Eshoo (D-CA) and ranking member Michael Burgess (R-TX); Oversight and Investigations subcommittee chair Diana DeGette (D-CO) and ranking member Brett Guthrie (R-KY).

Since 7/2018, there have been at least 15 recalls issued for angiotensin II receptor blockers (ARB), which 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 lawmakers said. “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.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome