Senate OTC Monograph Legislation Tracks House Bill On Exclusivity

Both bills allow 18-month market exclusivity periods for marketers of some products made available through additions or changes to OTC monograph, through which the majority of nonprescription drugs are made available in US. Senate bill in markup 31 October.

United States Capitol Building at sunset - Washington, DC, USA - Image

A difference that marked previous House and Senate bills that would modernize and overhaul the Food and Drug Administration's OTC monograph program is resolved as Sens. Bob Casey and Johnny Isakson introduce legislation mirroring a House bill introduced in June.

Casey, D-PA, and Isakson, R-GA, on 30 October introduced the Senate "Over-the-Counter Monograph Safety, Innovation, and Reform Act," S.2740, with language tracking the House bill,

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW 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

More from Legislation

More from Policy & Regulation