Bills To Speed Generic Entry Once Again Clear Senate Judiciary Committee

Legislation to prevent pay-for-delay deals, product hopping and sham citizen petitions, and to require the FTC to study the role of pharmacy benefit managers in the drug supply chain get unanimous committee vote. They may have a good shot at passage given recent actions by President Biden and the FTC, and bipartisan interest in drug pricing.

US Congress building
Senate Judiciary Committee advances bills to decrease prescription drug costs • Source: Alamy

The Senate Judiciary Committee has cleared four bills intended to address the high prices of prescription drugs by prohibiting practices that delay the launch of generic products. The bills now go to the Senate floor where they have a chance of passage given recent actions by the Biden Administration, the US Federal Trade Commission, and bipartisan interest in drug pricing.

Versions of the bills – which address so-called pay-for-delay deals, product hopping, citizen petitions to the US Food and Drug Administration, and pharmacy benefit managers – were introduced in the...

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

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Korean Pharma Industry Proposes Policies As Election Nears

 
• By 

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

More from Pink Sheet

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By 

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.