Senate toughens drug safety supervision in PDUFA bill

The Senate backed a version of PDUFA reauthorization that gives the FDA the authority to levy fines for false and misleading drug ads while adding new systems to monitor drug safety after therapeutics go on the market. Vermont Senator Bernie Sanders cast the lone dissenting vote of the 94 votes cast, saying that he objected because the bill failed to allow for drug imports from Canada and that it did nothing to rein in the billions of dollars spent on drug promotions. The vast majority of the Senate, though, saw the bill as a big step forward. Even Public Citizen, a tireless critic of the biopharma industry, said that the measure would improve drug safety, even as it castigated the user fees the industry pays the FDA. PDUFA comes up for reauthorization every five years and this year has seen heated debate over the contribution that the industry makes to the federal agency in exchange for a set timetable on marketing decisions.

- read the report from The Washington Post