OTC Monograph Reform Could ‘Unlock’ Innovations In Three Years

Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.

Significant nonprescription drug innovations likely would start to reach the market within just a few years after an overhaul of US FDA's OTC monograph program, the industry trade group Consumer Healthcare Products Association predicts. It suggests manufacturers will make proposals for formulation and other changes that they've been sitting on due to the current system's problems.

"We know a lot of companies have ideas like this they’ve kind of put in a drawer, that we think...

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

More from Legislation

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By 

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.

Biktarvy, Trikafta Affected As Medicaid Cuts Could Increase Patient Assistance Demands

 
• By 

Patient access to mental health drugs also will be challenged by the policies in the new budget reconciliation legislation.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By 

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

More from Pink Sheet

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.