Drugs

Defense Bill Language Could Usurp FDA Emergency Approvals

Legislative language in an FY 2018 Defense Department spending bill would give the military the authority to approve the emergency use of medical products, outside the U.S., in situations in which an emergency use of an unapproved product or an emergency unapproved use of an approved product cannot be authorized under FDA’s current statutory authority. The bill, S.1519 — National Defense Authorization Act for Fiscal Year 2018, is currently being reviewed by a conference committee. Politico reports that congressional staff and Health and Human Services officials are alarmed because it would undermine FDA’s role and “potentially put soldiers at risk.”

A Senate conference report notes that “hemorrhage is a leading cause of survivable death from battlefield wounds, and complex blood components, when used in a battlefield environment, can quickly control hemorrhage and save lives. Traditional pathways to the Food and Drug Administration's approval and licensure of critical medical products, like freeze dried plasma, for battlefield use are too slow to allow for rapid insertion and use of these products on the battlefield. The committee believes this provision could lead to even higher survival rates from severe battlefield wounds suffered by service members.

Politico was told by congressional staff that the report language is so broad it would open the door for the military to approve a wide range of products and treatments. “For instance, the Defense Department could plausibly approve a vaccine for soldiers who come down with the flu while deployed,” one congressional aide told Politico.

FDA reportedly offered an alternative proposal, which would have expedited drug and device reviews and approval upon a Defense Department request, but the language wasn’t accepted. Agency officials declined to comment on the report because it does not comment on 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