Woodcock Warns Against REMS Bills That Could Expose FDA To Lawsuits

FDA drug center chief Janet Woodcock urged Senate lawmakers Wednesday (Sept. 12) to tread carefully in their efforts to stop brand companies from restricting access to drug samples for generic development, warning that requiring “a lot of extra steps” might lead companies to sue FDA or file citizen petitions that could further delay generics. She also cast doubt on other penalties, saying “fines and everything might simply be considered a cost of doing business because there's so much at stake...