1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Legislation

Trump Budget: FDA-Regulated Firms Should Pay 'Their Share' In User Fees

 
• By Sue Darcey and David Filmore

President Trump's initial budget plan for US FDA would, it appears, make industry-paid user fees a much larger proportion of the agency's budget, but details are lacking. As is, the plan could complicate agreements that came out of FDA-industry user-fee negotiations last summer, but observers say this is just the first step in a process and Congress will ultimately decide. Trump would also shave 22% from the National Institutes of Health.

MT1610_StackedCoinsFEES_1200x675

A budget "blueprint" from the Trump administration asks for a major increase in user fees collected from medical-product companies in FY 2018 compared to what firms have agreed to. Meanwhile, the proposal appears to seek a significant reduction in funds provided by Congress to the agency for pre-market reviews, but details are lacking.

As is, the proposal could be a source of complication as the industry pushes for speedy reauthorization of the device user-fee program based on an agreement inked with the Obama...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

More from Policy & Regulation

Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.