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Tarceva Off-Label Marketing Caused 'Earlier' Death, DOJ Alleged

 
• By Brenda Sandburg

Roche and OSI Pharmaceuticals to pay $67m to resolve claims they misrepresented Tarceva effectiveness, diverting patients from first-line treatments and causing them to "die earlier and faster;" in other late-week legal developments, Salix settles kickback claims and former sales reps seemingly from Insys are arrested for fentanyl kickbacks.

The Department of Justice has gone after a long line of companies for off-label marketing. But its complaint against Roche's Genentech Inc. unit and OSI Pharmaceuticals LLC stands out for claiming their promotion of the non-small cell lung cancer drug Tarceva (erlotinib) as a first-line treatment caused patient to "die earlier and faster, with more pain."

Genentech and OSI, which co-promote Tarceva, reached a $67m settlement with DOJ and several states to resolve allegations that they...

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US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

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Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK-Wide Strategy Needed To Move Clinical Trial Diversity Plans To Next Stage

 
• By Vibha Sharma

The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.