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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

House passes sweeping election and anti-corruption bill

Photo: Win McNamee via Getty Images

The House voted 220-210Wednesday to pass Democrats' expansive election and anti-corruption bill.

Why it matters: Expanding voting access has been a top priority for Democrats for years, but the House passage of the For the People Act (H.R. 1) comes as states across the country consider legislation to rollback voting access in the aftermath of former President Trump's loss.

Updated 1 hour ago - Politics & Policy

House passes George Floyd Justice in Policing Act

Photo: Stephen Maturen via Getty Images

The House voted 220 to 212 on Wednesday evening to pass a policing bill named for George Floyd, the Black man whose death in Minneapolis last year led to nationwide protests against police brutality and racial injustice.

Why it matters: The legislation overhauls qualified immunity for police officers, bans chokeholds at the federal level, prohibits no-knock warrants in federal drug cases and outlaws racial profiling.

3 hours ago - Politics & Policy

Senate Republicans plan to exact pain before COVID relief vote

Sen. Ron Johnson. Photo: Stefani Reynolds/Bloomberg via Getty Images

Republicans are demanding a full, 600-page bill reading — and painful, multi-hour "vote-a-rama" — as Democrats forge ahead with their plan to pass President Biden's $1.9 trillion COVID-19 relief package.

Why it matters: The procedural war is aimed at forcing Democrats to defend several parts the GOP considers unnecessary and partisan. While the process won't substantially impact the final version of the mammoth bill, it'll provide plenty of ammunition for future campaign messaging.

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