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FTC’s PBM Investigation Could Yield Litigation Over Insulin Contracting

 
• By Cathy Kelly

The US Federal Trade Commission’s focus on potential anti-competitive behavior by pharmacy benefit managers picks up steam as Chair Lina Khan approaches the end of her term.

Is the FTC Poised To Challenge PBMs in Court? • Source: Shutterstock

The Federal Trade Commission’s interim report on the findings of its two-year investigation of pharmacy benefit managers flags “exclusionary rebating” as warranting further scrutiny as media reports surface that the commission may sue the three largest PBMs over their insulin contracting practices.

“Consistent with our commitment to share information with the public and policymakers as quickly as possible, we … confirm several...

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More from Market Access

Big PBM Dominance Enabled By Affiliated Third Party Administrators Limiting Choices, FTC Told

 
• By Cathy Kelly

Complaints about TPAs offer an explanation of why self-funded employers continue to use the big three PBMs despite concerns about those relationships. Proposed solutions include banning retaliatory fees and data withholding.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 
• By Eliza Slawther

Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
• By Cathy Kelly

Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.

Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
• By Cathy Kelly

Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.

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Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

England’s NICE Hunts For New Chief As Sam Roberts Prepares To Step Down

 
• By Eliza Slawther

Sam Roberts, chief executive of the health technology assessment institute, NICE, will step down from her role at the end of the year. The agency is now on the lookout for a new leader, who will be the fourth in its history.

NDA User Fees Will Grow 8.6% Next Year As FDA Projects More Applications But Fewer Sponsor Meetings

 
• By Nielsen Hobbs and Derrick Gingery

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.