Two of the drug makers facing the largest number of personal injury suits have opted to settle during the last year rather than go through extended litigation. Bayer Corp. has resolved approximately 9,200 claims alleging injuries from its birth control pills Yasmin and Yaz while Boehringer Ingelheim Pharmaceuticals Inc. agreed to a master settlement resolving 4,590 claims against its blood thinner Pradaxa (dabigatran).
Product Liability Suits: Testosterone, Lipitor Grow While Yaz, Pradaxa Settle
2014 saw some big settlements in personal injury suits involving Rx drugs, but it’s unclear whether this is a trend or just situation-specific decision-making, since fierce litigation continues for many other products.
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Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.