FDA won’t send pink slips in August

FDA Commissioner Scott Gottlieb told staff that if the Senate enters recess without reauthorizing medical product user fees, the agency will not send reduction in force notices (RIF), commonly known as pink slips, to employees. In an email to agency staff, he wrote that he is “optimistic” that the Senate will soon consider the FDA Reauthorization Act (FDARA), which reauthorizes PDUFA and user fees for generic drugs, biosimilars and medical devices. The House has already passed FDARA.

Gottlieb's email said he has been "in regular communication with Members of Congress, many of whom have expressed their high degree of confidence that FDARA will be enacted before the authorizations lapse.” The current user fee bills sunset on Sept. 30. ...