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Co-Pay Charity Settles Charges It Conspired With Teva, Biogen, Novartis On Kickbacks

 
• By Cathy Kelly

The Assistance Fund directed donations received from the companies to patients taking their multiple sclerosis drugs, the US Department of Justice announced. Further settlements may be pending.

Washington DC, USA-June 5, 2018: Robert F Kennedy Department of Justice building entrance "The Place of Justice is a Hallowed Place" engraved in stone above the door
Settlement Is Latest In DoJ's Industry-Wide Probe

An Orlando, Fla.-based foundation called The Assistance Fund has settled allegations by the Department of Justice that it violated the False Claims Act by enabling Teva Pharmaceutical Industries Ltd., Novartis AG and Biogen Inc. to pay kickbacks in the form of co-pay assistance to Medicare patients taking the companies’ multiple sclerosis drugs, the US Department of Justice announced 20 November.

The settlement involves a $4m fine and TAF entering into an integrity agreement designed to ensure it operates independently going forward and that its arrangements and interactions with pharmaceutical companies...

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PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.

US FDA’s Familiar Drug Pricing To-Do List

 
• By Michael McCaughan

President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.