Pharma Pricing, Non-Profit Ties Get Increasing Scrutiny From Prosecutors

Off-label marketing and kickbacks may no longer be the top targets of government healthcare fraud investigations as more companies are being hit with subpoenas for pricing information.

United States Department of Justice headquarter building in Washington D.C.

Drug makers have been unable to shake free of government investigations of their marketing and sales practices. But the focus of the probes has shifted in the last few years and one word now routinely pops up – pricing.

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US FDA Forced To Rip Up, Start Biosimilar First Interchangeable Exclusivity Guidance Again

 

New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.

Sandoz Pays Another $275m Over Price-Fixing

 
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Sandoz announced a $275m settlement to resolve class action antitrust litigation over price-fixing allegations and disclosed that the company made a further provision of $265m linked to the case.

Rx Enforcement In 2025: Shift Away From Opioid Makers But Tougher Approach On Ad/Promo

 
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The compounding industry ties for Martin Makary, President-elect Trump’s candidate to lead the FDA, could mean less compounding enforcement, experts said, but government officials said their enforcement focus will remain nonpartisan.

US FDA Takes Lilly’s Mounjaro, Zepbound Off Shortage List But Gives Compounding Grace Period

 
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Compounding pharmacies have 60 days, and outsourcing facilities 90 days, to transition patients to branded products.

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Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations

 
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Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.

Spanish Health Ministry Targets Efficiency With New Medicine Pricing Rules

 

A draft royal decree would pave the way for more transparency in pricing and reimbursement decision-making processes and boost competition to increase the participation of generic medicines.

EU Biosimilar Filings, Opinions And Approvals

 

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.