Get the latest market trends in your inbox

Stay on top of the latest market trends and economic insights with the Axios Markets newsletter. Sign up for free.

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Denver news in your inbox

Catch up on the most important stories affecting your hometown with Axios Denver

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Des Moines news in your inbox

Catch up on the most important stories affecting your hometown with Axios Des Moines

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Minneapolis-St. Paul news in your inbox

Catch up on the most important stories affecting your hometown with Axios Minneapolis-St. Paul

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Tampa-St. Petersburg news in your inbox

Catch up on the most important stories affecting your hometown with Axios Tampa-St. Petersburg

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!

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

Microwave energy likely behind illnesses of American diplomats in Cuba and China

Personnel at the U.S. Embassy in Cuba in Havana in 2017, after the State Department announced plans to halve the embassy's staff following mysterious health problems affecting over 20 people associated with the U.S. embassy. Photo: Sven Creutzmann/Mambo photo/Getty Images

A radiofrequency energy of radiation that includes microwaves likely caused American diplomats in China and Cuba to fall ill with neurological symptoms over the past four years, a report published Saturday finds.

Why it matters: The National Academies of Sciences, Engineering, and Medicine's report doesn't attribute blame for the suspected attacks, but it notes there "was significant research in Russia/USSR into the effects of pulsed, rather than continuous wave [radiofrequency] exposures" and military personnel in "Eurasian communist countries" were exposed to non-thermal radiation.

Georgia governor declines Trump's request to help overturn election result

Georgia Gov. Brian Kemp. Photo: Elijah Nouvelage/Getty Images

Georgia Gov. Brian Kemp pushed back on Saturday after President Trump pressed him to help overturn the state's election results.

Driving the news: Trump asked the Republican governor over the phone Saturday to call a special legislative session aimed at overturning the presidential election results in Georgia, per the Washington Post. Kemp refused.

Get Axios AM in your inbox

Catch up on coronavirus stories and special reports, curated by Mike Allen everyday

Please enter a valid email.

Please enter a valid email.

Subscription failed
Thank you for subscribing!