Drugs

Leave Battlefield Medical Decisions to FDA: Senate Vote

By unanimous consent, the Senate agreed 11/16 to a House bill leaving to FDA decisions for battlefield drugs and medical devices. The House adopted HR 4374, introduced by Rep. Greg Walden (R-OR) the day before the Senate vote.

The bill is intended to correct a provision adopted by the House in the $700 billion defense bill known as the National Defense Authorization Act (NDAA) that would have given authority to the Defense Department to make emergency approvals of battlefield drugs and medical devices.

S&P Global reports in an online post that FDA commissioner Scott Gottlieb had raised concerns about giving the Defense Department drug and device approval authority and had publicly backed alternative legislation.

In an 11/14 letter to key Republicans and Democrats on the Senate Armed Services Committee, the commissioner reportedly said he would make battlefield products one of his highest priorities.

Walden’s bill is expected to streamline the process for battlefield drugs, the post says, by establishing a deadline for FDA, requiring that once the Defense Department makes a declaration of an imminent risk of attack, the HHS secretary would have a maximum of 45 days to declare that such a risk exists.

The bill also lifts the limit on the types of threats FDA can declare are emergencies, allowing the agency to go beyond chemical, biological, radiological, or nuclear agents.

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