House Passes US OTC Monograph Reform And Committee Clears HSA Change

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

Washington DC Capitol dome detail with waving american flag

The US House of Representatives has been busy on consumer health products policy, making progress on one proposal to streamline how FDA evaluates OTC monograph proposals and another on how consumers can pay for nonprescription drugs.

On July 16, the full chamber passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333. It...

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.