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.
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.
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New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
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.
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.
Compounding pharmacies have 60 days, and outsourcing facilities 90 days, to transition patients to branded products.
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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.
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.
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.