Nov 10, 2017

New deal would keep Pentagon out of product approvals

Lawmakers are approaching a bipartisan deal to resolve the ongoing dispute over whether to let the Defense Department approve medical products in an emergency, Sen. Patty Murray told me yesterday.

The issue: A provision in this year's defense authorization bill would permit the Defense Department to allow the use of certain medical products — such as freeze-dried plasma — on the battlefield, even if they haven't been approved by the Food and Drug Administration.

  • That touched off a bipartisan rebellion from members of the Senate HELP Committee, who feared the provision would undermine the FDA's authority and the rigorously controlled process it uses to evaluate new treatments.

The deal: Product reviews remain solely within the FDA's jurisdiction, but would give the Pentagon new powers to get the FDA to expedite those reviews, according to the agreement reached between Murray and Sen. Lamar Alexander.

  • Under the agreement, if the defense secretary asks for it, the FDA "shall take action to expedite the development and review of an applicable application" for relevant medical products.
  • Officials from the FDA would have to meet quarterly with Pentagon officials to figure out the military's top priorities (the bill specifically mentions freeze-dried plasma as one of those priorities).
  • The FDA already has the power to allow the use of unapproved drugs in emergency situations, as it did with experimental Ebola treatments in 2014, and the Pentagon can already have a say in that process. This agreement would tweak those rules to give the Pentagon some more flexibility.

What's next? A Senate committee aide told me this is the deal that's likely to become final. While it's not clear how this would get passed — on its own or as an attachment to something else— Congress does not seem interested in slowing down the defense bill to address this.

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Trump announces 30-day extension of coronavirus guidelines

President Trump announced on Sunday that his administration will extend its "15 Days to Slow the Spread" guidelines until April 30 in an effort to stop the spread of coronavirus, which has now infected more than 130,000 Americans and killed nearly 2,500.

Why it matters: Top advisers to the president have been seeking to steer him away from Easter as an arbitrary deadline for the U.S. to open parts of its economy, amid warnings from health officials that loosening restrictions could cause the number of coronavirus cases to skyrocket.

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Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 5 p.m. ET: 716,101 — Total deaths: 33,854 — Total recoveries: 148,900.
  2. U.S.: Leads the world in cases. Total confirmed cases as of 5 p.m. ET: 136,880 — Total deaths: 2,409 — Total recoveries: 2,612.
  3. Federal government latest: The first federal prisoner to die from coronavirus was reported from a correctional facility in Louisiana on Sunday.
  4. Public health updates: Fauci says 100,000 to 200,000 Americans could die from virus.
  5. State updates: Louisiana governor says state is on track to exceed ventilator capacity by end of this week — Cuomo says Trump's mandatory quarantine comments "panicked" some people into fleeing New York
  6. World updates: Italy on Sunday reports 756 new deaths, bringing its total 10,779. Spain reports almost 840 dead, another new daily record that bring its total to over 6,500.
  7. What should I do? Answers about the virus from Axios expertsWhat to know about social distancingQ&A: Minimizing your coronavirus risk
  8. Other resources: CDC on how to avoid the virus, what to do if you get it.

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Trump touts press briefing "ratings" as U.S. coronavirus case surge

Photo: Drew Angerer/Getty Images

President Trump sent about a half-dozen tweets on Sunday touting the high television ratings that his coronavirus press briefings have received, selectively citing a New York Times article that compared them to "The Bachelor" and "Monday Night Football."

Why it matters: The president has been holding daily press briefings in the weeks since the coronavirus pandemic was declared, but news outlets have struggled with how to cover them live — as Trump has repeatedly been found to spread misinformation and contradict public health officials.