340B Sales Reach New Heights: Legislative Reform Prospects Depend On US Elections

Drug discount program reform would have the best chance of enactment if Republicans gain control of both the House and Senate and former president Trump is re-elected.

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340B Sales are Setting New Records Each Year. (Shutterstock)

Sales in the 340B outpatient drug discount program rose 23.4% to $66bn in 2023, according to the Health Resources and Services Administration, continuing a string of mostly 20%-plus increases in the program’s sales since 2015.

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Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies

 
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A Republican think tank suggested variations of the Most Favored Nation and international reference policies in Medicare and Medicaid, as well as tariffs and other trade levers to rebalance drug pricing disparities between US countries and abroad.

CMS Nominee Oz Nears Confirmation Despite Concerns About Medicaid Cuts

 
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Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.

Branded Pharma And Generics Industries At Odds Over UK VPAG Framework

 

The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.

‘Hope And Scientific Spillover’ – Cross-Atlantic HTA Alliance To Focus On Novel Benefits

 

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Germany: Standardized Clauses In Clinical Trial Agreements Bring Opportunities But Also Tougher Negotiations

 

Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.

EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.

EU Pharma Reform: Negotiations Could See Patient Voice ‘Discarded,’ Warn Patient Groups

 

An enhanced role for patients in the European Medicines Agency was a key proposal within the EU pharmaceutical legislation overhaul – but patient groups warn this provision could be scrapped or weakened due to ongoing negotiations.