Cross-posted on Notice & Comment.
On August 18, the President signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorized FDA to collect user fees in connection with new drugs, biologics, and medical devices for human use. These user fee programs are colloquially known as PDUFA (innovator drugs and biologics), GDUFA (generic drugs), BsUFA (biosimilars), and MDUFMA (medical devices).
The White House had been urging Congress to change the structure of FDA’s user fee programs so that much of the agency’s programming is funded by user fees rather than appropriations. Congress has more FDA user fee programs to reauthorize, however, and the Administration’s basic proposal is unlikely to go away. I explain more of the history and the debate below.