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Value-Based Contracting Needs Federal Safe Harbors To Flourish, Lilly Says

 
• By Cathy Kelly

Lilly USA Deputy General Counsel Weems and former Anthem Chief Medical Officer Nussbaum offer insights on how guidance from the HHS Inspector General might help advance value-based contracting.

Some of the legal and regulatory obstacles to value-based contracting between biopharma manufacturers and payers could be cleared with the help of guidance from the HHS Office of Inspector General designating specific safe harbors, Eli Lilly & Co. VP and Deputy General Counsel (USA) Alonzo Weems commented at a recent conference in Washington DC.

“This is one very specific step the OIG can take, to issue new or updated compliance guidance to manufacturers, specifically...

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US Return Of GSK’s Blenrep Threatened By Ocular Toxicity, Dosage Optimization Questions

 
• By Sue Sutter

The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

More from North America

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

 
• By Sarah Karlin-Smith

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.

‘Seize the Moment:’ European Drug Regulators Called To Act On Changes In US

 
• By Francesca Bruce

European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines Agency 30th anniversary.

US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.