Schering-Plough posted a fourth quarter loss on charges related to its acquisition of Organon and said it was ready to take action if sales of Vytorin and Zetia decline significantly.

FDA issued an "early communication" advising that it is looking into adverse reactions to Botox and Botox Cosmetic that have been blamed for hospitalizations and even deaths -- mostly in children treated for cerebral palsy-associated limb spasticity, an off-label usage.

After being scrapped for 2008, the FDA's plan for premarket review of television advertisements may yet appear. The agency's proposed 2009 budget includes an increase of $14 million for direct-to-consumer (DTC) TV ad review.

The National Institutes of Health doles out billions to universities for research without ensuring grantees' compliance with federal financial conflict-of-interest regulations, a government report found.

Merck/Schering-Plough launched patient education ads for Vytorin and Zetia in newspapers over the weekend while temporarily suspending broadcast advertising for the brands.

Congress is investigating the use of celebrity endorsements in pharmaceutical advertising - starting with a "celebrity physician," artificial heart inventor Dr. Robert Jarvik.

The District of Columbia Council approved legislation on Jan. 8 that would require pharmaceutical sales representatives to obtain licenses to operate within city limits, The Washington Post reports.

The lawyer for an ex-Pfizer employee bringing a whistleblower suit against Pfizer said he isn't phased by the government's decision to refrain from the case.

The FDA is set to issue draft guidance outlining criteria for dissemination of journal articles on off-label uses, a Congressman has found.

Cephalon said it will pay $425 million to settle a US Justice Department investigation into practices of off-label marketing of products including its pain reliever Actiq.