PBM Consolidation Should Be A Focus OF FTC Merger Guidelines Review, AAM Urges

As they revise and interpret merger guidelines, the Federal Trade Commission and Department of Justice should pay particular attention to the anticompetitive impact of consolidation in the pharmacy benefit manager market, the generic trade group suggests.

Insurer/PBM/Pharmacy Combinations Leading To Anti-Competitive Practices, Group Argues • Source: Alamy

Consolidation in the pharmacy benefit management industry has led to rebating practices that can hamper access to generic drugs and increase out-of-pocket costs for patients, the Association for Accessible Medicines told the Federal Trade Commission and the Department of Justice in 21 March comments

PBM consolidation threatens competition from lower cost generic drugs in “numerous ways,” AAM said. Noting that PBM’s have “dramatically” expanded...

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

 
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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.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
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The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

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Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

340B Rebate Model Gets HRSA Endorsement; Pilot Program Limited To Medicare Negotiated Drugs

 
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Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.

Sanofi Secures EU Fast-Track Status For ‘Game-Changing’ Sleeping Sickness Drug

 

If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.