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AP file photo

Senate and House health committee leaders have released the "discussion draft" of a bill to reauthorize the user fees that help fund the Food and Drug Administration. They have to be renewed by the end of September, but Senate HELP Committee chairman Lamar Alexander says he hopes to get it done before the August recess to avoid layoff notices to FDA employees. The HELP Committee plans to mark up the legislation on May 10, according to an aide.

Between the lines: They're making a point of sticking to the user fee agreements that were already negotiated — meaning they're ignoring President Trump's budget request, which calls for a doubling of the user fees that health care companies have to pay. And by stressing the urgency of getting to done before August, Alexander is sending a signal to both parties not to try to load it up with amendments. (Democrats might try to attach measures to bring down drug prices.)

Here are the highlights of the 34-page draft (a summary is available here):

  • It's based on the agreements that were already negotiated between the FDA, members of Congress, industry groups, and patients.
  • It covers user fees for FDA review of prescription drugs, medical devices, generic drugs, and biosimilars.
  • It changes the fee structure for prescription drugs and generics.
  • Allows fees to be collected for "de novo" medical devices (new ones that don't pose a lot of risk).
  • Creates an independent fee structure for biosimilars.

Go deeper

Ex-Theranos CEO describes alleged abuse by former boyfriend and company exec

Illustration: Aïda Amer/Axios

On her fourth day of trial testimony, ex-Theranos CEO Elizabeth Holmes described her 10-year romantic relationship with former president Ramesh "Sunny" Balwani as controlling, and said he would sometimes "force me to have sex with him when I didn’t want to."

Why it matters: While Balwani has also been similarly charged with fraud, the two are being tried separately, in part because some of Holmes' defense hinges on blaming him.

Amazon ordered to redo union vote in Alabama

Photo: Patrick Pleul/picture alliance via Getty Images

A U.S. National Labor Relations Board (NLRB) official on Monday called for a re-vote in a union election at an Amazon warehouse in Bessemer, Alabama.

Why it matters: The move could set the stage for another organizing drive at the e-commerce giant, which has, so far, fought off unionizing efforts in the U.S.

Pentagon to probe 2019 Syria strike after reports of dozens of civilian casualties

Secretary of Defense Lloyd Austin on Nov. 20. Photo: Mazen Mahdi/AFP via Getty Images

Defense Secretary Lloyd Austin has ordered a new investigation into a 2019 U.S. airstrike that killed around 80 people, including dozens of women and children in Syria, the New York Times reports.

Why it matters: The move comes after the Times reported this month that the Pentagon attempted to keep the strike and casualties under wraps, failing to investigate the decision behind it even after questions were raised internally.

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