• Warner Chilcott Warned by FDA for CGMP Violations in Birth Control Product

    The US Food and Drug Administration (FDA) sent pharmaceutical manufacturer Warner Chilcott a warning letter 8 March for perceived violations of current good manufacturing practices (cGMPs) at their Fajardo, Puerto Rico plant. In the letter, FDA notes pharmaceuticals manufactured at the plant were adulterated as a result of staff failing to investigate batch failures and out-of-specification components. Further, the plant was unable to verify whether adulterated batches h...
  • FDA Responds to Conflict of Interest Uproar

    The US Food and Drug Administration (FDA) responded to critics of an FDA advisory board decision on Tuesday, saying that critics of the decision exhibited a "lack of understanding about our selection and evaluation process, as well as federally mandated limitations on the type on information [FDA] can share" with the public. Utilizing the new FDA Voice blog, Jill Hartzler, acting associate commissioner for special medical programs, sought to clarify the agency's conf...
  • POGO Lambastes FDA Over Conflict of Interest Report

    The government watchdog group Project on Government Oversight (POGO) has aimed its sights on the US Food and Drug Administration (FDA) over reports that it allowed panelists with potential conflicts of interest to serve as voting members of an advisory committee, even as it took away the voting rights of a vocal critic of the product the advisory committee was voting on.p For further background, please see prior Regulatory Focus coverage here . The group, which calls ...
  • WSJ: Panel Assessing Bayer Birth Control Pills Had Ties to Company

    An advisory committee convened by the US Food and Drug Administration (FDA) to assess the safety of four Bayer AG birth control products had at least three members with ties to the company, according to The Wall Street Journal . The panelists, whose ties with Bayer included serving as consultants, speakers or researchers, did not have their ties to the company disclosed to the public by FDA. An FDA official, Jill Hartzler, told The Wall Street Journal that FDA ...