Drugs

House Committee Threatens FDA Subpoena

Republicans on the House Energy and Commerce Committee say there has been no response from FDA to their 7/18 request for information and documents about the agency’s foreign drug inspection program. In a 12/13 follow-up letter to FDA commissioner Robert Califf, the committee leaders say they are prepared to issue a subpoena if FDA does not produce the requested documents by 1/5/2024.

“The committee is concerned that HHS, including FDA, has made a deliberate decision to understaff and under-resource its ability to respond to oversight requests,” the letter says.

The legislators write that since their July letter, “it has come to light that FDA ended its unannounced foreign inspection program because the agency believed it was an obstacle to deeper collaboration with India. That same reporting also alleges that FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine FDA’s credibility. In addition, a newly published study has confirmed that FDA foreign inspections in 2022 were down 79% compared to 2019, while at the same time, the number of ‘citations rose dramatically, despite all establishments being given advance notice of inspections.’”

The letter reviews some foreign drug recalls that have occurred since the July letter and says that domestic production of vital medicines continues to be under stress.

“In short,” it says, “drug shortages plague our nation. The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions. Members of the committee have repeatedly expressed concern regarding the effectiveness of FDA’s foreign drug inspection program, including at two separate hearings in this Congress before the Subcommittee on Oversight and Investigations and the Subcommittee on Health.”

The committee stresses that addressing drug shortages remains a top priority and that it has a right to the requested information and documents that are necessary to carry out its constitutional oversight responsibilities and to inform pending legislation.

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