Senate user fee bill seeks diagnostics revamp

A day before the House Energy & Commerce Committee is slated to complete work on medical products user fee reauthorization legislation, the Senate Health, Education, Labor and Pensions Committee released a discussion draft of its version of a user fee reauthorization bill.

The Senate discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act does not include many of the key provisions in the House bill, including reform of the accelerated approval pathway, steps to enhance clinical trials diversity, and clarification of the Orphan Drug Act to allow FDA to grant separate exclusivities to subpopulations within an indication. ...