1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Generics

Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

 
• By Derrick Gingery

Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

Capitol House

House members will consider creating a generic drug priority review pathway different from one already proposed in the pending user fee agreement, although it may not prove faster in all cases. The bill would mandate a six-month priority review for generic applications for drugs with only one sponsor marketing them already or products on FDA's drug shortage list, and could apply to first generics. Those products also would become eligible for a priority review voucher upon approval.

Introduced on Jan. 30 by Reps. Kurt Schrader, D-Ore., and Gus Bilirakis, R-Fla., the bill is intended to help bring down the cost of some prescription drugs. The Energy and Commerce Committee plans to take up HR 749 next week, according to a statement from Chairman Greg Walden, R-Ore

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 Generics

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

More from Biosimilars & Generics

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.