1. Pink Sheet

340B Fight Escalates As Biden Administration Seeks Refunds From Manufacturers, Threatens Them With Fines

 
• By Cathy Kelly

Lilly, AstraZeneca, Novartis, Sanofi, Novo Nordisk and United Therapeutics ordered by HRSA to resume discounts to 340B contract pharmacies and refund past 'overcharges.'

Compliance
Dispute May Ultimately Bring Clarity To 340B Rules

The US Health Resources and Services Administration warned six drug manufacturers in recent letters that withholding or restricting 340B discounts to contract pharmacies violates the law and may be punishable by civil monetary penalties.

The letters, dated 17 May, mark the latest development in an ongoing dispute between manufacturers, 340B providers and the Health and Human Services Department (which houses HRSA) over whether manufacturers can restrict 340B discounts to pharmacies that process claims on behalf of eligible providers. A number of companies have implemented restrictions since the fall, led by Eli Lilly and Company

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 Legal & IP

More from Pink Sheet

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.