1. Pink Sheet
  2. >>Legislation

US FDA’s ‘Active Moiety’ Approach On NCE Exclusivity Codified Under Drug Pricing Legislation

 
• By Sue Sutter

Measure clarifies the meaning of new chemical entity by replacing the term ‘active ingredient,’ which encompasses esters and salts, with ‘active moiety’ as defined by the FDA; legal experts are skeptical the measure will generate cost savings and say it gives the agency wide latitude to make future changes in eligibility for 5-year exclusivity.

old door opens to space station
Legislative language on 'successor regulations' provides an opening to future changes in the FDA's definition of 'active moiety.'

A bill codifying the US Food and Drug Administration’s current approach to determining new chemical entity exclusivity appears to give the agency leeway to make future changes in how it defines potentially eligible drug products, legal experts said.

The Ensuring Innovation Act (S. 415) was signed by President Joe Biden on 23 April after passing the Senate...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

House Gives US FDA More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

More from Pink Sheet

UK MHRA Helps Sponsors Prepare For ‘World’s First’ Decentralized Manufacturing Framework

 
• By Neena Brizmohun

The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

What UK’s Clinical Trials Overhaul Means For Orphan Drug Developers

 
• By Eliza Slawther

The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.