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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 made misleading statements about the effectiveness of Tarceva for unapproved...

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US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.