Apr 14, 2017

Need some holiday reading? Here's an FDA user fees bill

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.

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Top Trump ally sounds 2020 election alarm over coronavirus response

Photo: Jim Watson/AFP via Getty Images

There is growing concern among top conservative leaders that the Trump administration isn't addressing the long-term economic impact of the coronavirus, several sources tell Axios. One top adviser said if the recovery is bungled it could cost President Trump the election.

What we're hearing: "The next 4-8 weeks is really going to decide whether Trump gets reelected," Stephen Moore, Trump's former nominee for the Federal Reserve board, told Axios. If the administration mishandles its economic recovery efforts, he said, Trump is "in big trouble."

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Global: Total confirmed cases as of 10 p.m. ET: 1,600,427 — Total deaths: 95,506 — Total recoveries: 354,006Map.
  2. U.S.: Total confirmed cases as of 10 p.m. ET: 465,329 — Total deaths: 16,513 — Total recoveries: 25,410Map.
  3. Public health latest: U.S. has expelled thousands of migrants under a CDC public health orderDr. Anthony Fauci said social distancing could reduce the U.S. death toll to 60,000.
  4. Business latest: The Fed will lend up to $2.3 trillion for businesses, state and city governments — After another 6.6 million jobless claims, here's how to understand the scale of American job decimation.
  5. 2020 latest: Top conservative leaders are concerned the Trump administration isn't addressing the virus' long-term economic impact.
  6. States latest: FEMA has asked governors to decide if they want testing sites to be under state or federal control.
  7. World latest: Lockdowns have led to a decline in murders in some of the world's most violent countries — Boris Johnson is moved out of the ICU but remains in hospital with coronavirus.
  8. In Congress: Senate in stalemate over additional funding for small business relief program.
  9. 1 SNL thing: "Saturday Night Live" will return this weekend in a remotely produced episode.
  10. What should I do? Hydroxychloroquine questions answeredPets, moving and personal healthAnswers about the virus from Axios expertsWhat to know about social distancingQ&A: Minimizing your coronavirus risk.
  11. Other resources: CDC on how to avoid the virus, what to do if you get it.

Subscribe to Mike Allen's Axios AM to follow our coronavirus coverage each morning from your inbox.

Federal court temporarily blocks coronavirus order against some abortions

Gov. Greg Abbott. Photo: Tom Fox-Pool/Getty Images

A federal judge ruled Thursday that clinics in Texas can immediately offer medication abortions — a pregnancy termination method administered by pill — and can also provide the procedure to patients nearing the state's time limits for abortions.

Driving the news: The decision comes after federal appeals court ruled 2-1 on Tuesday in favor of an executive order by Republican Gov. Greg Abbott that prohibits abortions during the coronavirus outbreak.

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