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PBM Transparency Act Advances In Senate And It’s A Far Cry From The Rebate Rule

 
• By Cathy Kelly

Bill aims to lower patient costs in part by engaging the US Federal Trade Commission to shed light on pharmacy benefit manager transactions with health plans, manufacturers and pharmacies.

Bill A Small Step In The Right Direction? • Source: Shutterstock

The pharmacy benefit manager transparency legislation now pending in the Senate takes a much more incremental approach to reining in pharmacy benefit manager practices than the Trump-era Medicare rebate rule.

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African Medicines Agency Set To Launch With New Leader In April

 
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The African Medicines Agency is to appoint a director general and become operational at the end of this month.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
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The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
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Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.

New Medicare Negotiation Program ‘Iterations’ Inevitable, Former CMS Official Blum Says

 
• By Cathy Kelly

Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.

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African Medicines Agency Set To Launch With New Leader In April

 
• By Anabel Costa-Ferreira

The African Medicines Agency is to appoint a director general and become operational at the end of this month.

China Plans Clinical Data Protection By Product Category For First Time

 
• By Xu Hu

After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
• By Sue Sutter

Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.