Senators Ask Drugmakers To Explain Shortages Of RSV Drug For Infants

The Hill: Senate Democrats Demand Answers From Manufacturers Over RSV Drug Shortage
In a letter led by Sen. Tammy Duckworth (D-Ill.) sent Friday, the lawmakers asked manufacturers AstraZeneca and Sanofi for more information about the current supply of nirsevimab, when the companies first became aware of the shortage, and why they were so unprepared for the demand. “As our nation braces for the 2023-2024 RSV season, we are concerned that health care providers and families are having difficulty accessing this new immunization product that can be used to prevent severe RSV infections in infants,” the senators wrote. (Weixel, 11/17)

From the White House —

Politico: Biden Campaign Facing Heat Over Plans To Deal With His Age
At the Democratic National Committee’s September fundraiser retreat, a donor pressed Joe Biden’s deputy campaign manager, Quentin Fulks, about one of the more oft-discussed topics in party circles: the president’s age. How, the person asked during a question-and-answer session on the 2024 campaign, should donors handle the stream of concerns they’ve heard about it? Fulks acknowledged the obvious: You can’t change the age of the president, who will turn 81 on Monday. Instead, he advised the donor to focus on Biden’s historic accomplishments. (Schneider, Otterbein and Lemire, 11/19)

Stat: National Cancer Institute Gets New Leader, A Vanderbilt Oncologist
President Biden on Friday said he plans to appoint cancer researcher and doctor Kimryn Rathmell to lead the National Cancer Institute. Rathmell will assume leadership of the $7.3 billion agency amid the administration’s efforts to relaunch Biden’s Cancer Moonshot initiative with an emphasis on screening, prevention, and better treatment. Her work over the years has focused primarily on kidney cancer and its underlying drivers. (Owermohle, 11/17)

In news concerning the FDA —

Stat: Medtronic High Blood Pressure Device Wins FDA Approval 
The Food and Drug Administration has approved a Medtronic device to lower blood pressure, the company announced Friday evening. The decision comes after an advisory panel narrowly voted against the device in August. The FDA approved a similar product, part of a device class called renal denervation, from startup Recor Medical earlier this month. (Lawrence, 11/17)

Reuters: US FDA Approves Medtronic's Blood Pressure Treatment Device For Use
The U.S. Food and Drug Administration on Friday approved the use of Medtronic's (MDT.N) treatment device in a surgery called renal denervation in patients whose high blood pressure cannot be controlled by drugs, the company said. The agency's decision is in contrast with the recommendation of a panel of independent experts, who narrowly voted against allowing the use of the device in August. (11/18)

CBS News: Court Orders Balance Of Nature To Stop Sales Of Supplements After FDA Lawsuits
A federal court ordered the brand Balance of Nature to stop producing and selling its dietary supplement products this week, after the Food and Drug Administration accused the two Utah-based companies behind it of repeatedly breaking the law in how they made and marketed their supplements. The FDA says the company marketing Balance of Nature, Evig LLC, and its CEO Lex Howard had flouted years of federal warnings about overstepping limits in what they could claim about diseases their supplements could cure or prevent. (Tin, 11/17)

Reuters: FDA Identifies Recall Of B. Braun Medical Pump System As Most Serious 
The U.S. Food and Drug Administration (FDA) on Friday said it had identified the recall of B. Braun Medical Inc's medicine-delivering pump system as most serious. The Pennsylvania-based company had recalled some models of its Infusomat Space Volumetric infusion pump system in September due to faulty occlusion alarms, which may cause the pump to stop the delivery of medications pre-emptively or cause interruption. (11/17)

Reuters: FDA Panel Flags Insufficient Data For Merck's Chronic Cough Drug
Advisers to the U.S. health regulator said on Friday that data on Merck's (MRK.N) chronic cough drug does not provide sufficient evidence to prove its clinical benefit for patients. The U.S. Food and Drug Administration's (FDA) panel voted 12 to 1 against the late-stage data submitted by Merck for the drug gefapixant, which showed a small reduction in cough frequency compared to a placebo. (Mandowara and Santhosh, 11/17)

Also —

KFF Health News: US Military Says National Security Depends On ‘Forever Chemicals’
The Department of Defense relies on hundreds, if not thousands, of weapons and products such as uniforms, batteries, and microelectronics that contain PFAS, a family of chemicals linked to serious health conditions. Now, as regulators propose restrictions on their use or manufacturing, Pentagon officials have told Congress that eliminating the chemicals would undermine military readiness. (Kime, 11/20)