Drugmakers concerned about legal risk with FDA review program, Reuters reports

More than half a dozen major drugmakers are participating in the Trump administration’s expedited FDA review program, but several leading firms are hesitant due to potential legal and safety risks, Reuters’ Maggie Fick and Patrick Wingrove report. Executives cited concerns that a two month review could compromise scientific rigor, undermine FDA credibility, and expose companies to litigation if serious side effects emerge after approval, according to the report. Publicly traded companies in the space include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).