GDUFA Fee Waivers Floated During Generic Drug Pricing Senate Hearing

FDA's generic drug user fee program came under fire Thursday (Nov. 20) during a congressional hearing investigating the cause of generic drug price increases, with one witness suggesting FDA should fast-track applications and waive user fees for products that if approved would break up monopolies. Sen. Richard Burr (R-NC), ranking member on the Senate health committee's panel on primary health and aging, called GDUFA a “burden” and cited longer wait times for generic drugs to be approved as a result...