Following US Senate and House pass of FDA reforms, now comes the detail

Now that the US House of Representatives and the Senate have passed HR 5651 and S 3187 (the FDA Safety and Innovation Act), respectively, focus will move to a conference committee, which will iron out differences between the bills and reach a compromise, comments Karl Karst on law firm Hyman, Phelps & McNamara’s FDA Law Blog.

Both bills reauthorize and amend old (PDUFA and MDUFA) and establish new (GDUFA and BsUFA) user fee statutes, permanently reauthorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, and create several new provisions of law, among other things, he notes.

There are many differences between the Senate and House bills – some major and some minor – although the user fee provisions in both bills are almost identical. The Senate bill includes provisions on drug track and trace, Risk Evaluation and Mitigation Strategies, and changes to the Controlled Substances Act not included in the House bill.