Tag Archives: OPDP
Tom Abrams: Caronia Won't Stop Off-Label Enforcement
The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.
Posted in Advertising, Agency Insight, E-Media, FDA, Legal, Marketing, Regulatory, leadership, social media Also tagged CBI, FDA, First Amendment, misbranding, off-label, Tom Abrams, US v. Caronia 1 Comment
Bristol-Myers Squibb's Summertime Blues
The sun was shining, savory scents were floating out from the grill, the lemonade was mixed and the table was set. But then dark clouds blew in and settled overhead. Bristol-Myers Squibb’s (BMS) picnic got rained out this summer.
One element of the rain out was forecasted long ago; Plavix, the multibillion dollar [...]
Posted in Advertising, Biotech, Deals, FDA, Legal, Marketing, R&D, Regulatory, Safety, Sales, Strategy, compliance, pricing Also tagged Bristol-Meyers Squibb, FDA, Office of Prescription Drug Promotion, Regulatory, Untitled Letter Leave a comment
Genentech Runs Voluntary Corrective Ads for Boniva
Even though Roche-owned Genentech wasn’t required to run costly corrective advertisements following an FDA Untitled Letter on Boniva last January, the company has done so anyway.
Posted in Advertising, Corporate Responsibility, FDA, Legal, Marketing, Regulatory, compliance, leadership Also tagged DDMAC, Genentech, Roche Leave a comment

Following Industry, OPDP Hopes to Eliminate Silos in Ad Review