Tag Archives: OPDP

Social Media Raise Concerns for Marketers, Trial Sponsors

While biopharmaceutical companies are using websites and third-party postings to provide information on medical products — despite a host of regulatory issues — social media use is in its infancy related to the design and conduct of clinical trials. A recent report from the Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) finds that […]
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Following Industry, OPDP Hopes to Eliminate Silos in Ad Review

The Office of Prescription Drug Promotion (OPDP) is reorganizing its two primary advertising review divisions – professional and consumer – in an attempt to stay in line with the silo-breaking, multi-channel promotional output pouring in from pharma. The line between physician marketing and consumer marketing has blurred as the facets of a brand campaign – […]
Posted in Advertising, compliance, E-Media, FDA, Legal, Marketing, Patient Communication, patient education, Regulatory, Sales, social media | Also tagged , , | Leave a comment

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, leadership, Legal, Marketing, Regulatory, social media | Also tagged , , , , , , | 1 Comment

Forest Labs Hit with Bad Ad Tattle

Forest Labs has had a tough time with regulators over the last two years. The company’s sales reps can’t seem to stop breaking the law. The latest offense, which generated an Untitled Letter from the Office of Prescription Drug Promotion (OPDP), was brought to light through OPDP’s Bad Ad program, which encourages physicians to report […]
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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 blood-thinner, second […]
Posted in Advertising, Biotech, compliance, Deals, FDA, Legal, Marketing, pricing, R&D, Regulatory, Safety, Sales, Strategy | Also tagged , , , , | Leave a comment
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