Senate leaders now say they won’t consider companion legislation to the House-passed 21st Century Cures Act until September, after months of delay. Lawmakers would then have to reconcile the differing House and Senate versions, presumably by year’s end during a lame-duck Congress.
We believe the summer delay is a good thing, and that Congress should actually extend consideration of the complex legislation into 2017 when must-pass FDA funding through industry user-fees will be on the congressional calendar. That way, lawmakers can debate the implications of the proposed bills in the context of the resources FDA needs.
Why further delay? Because the legislation—which makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices—is flawed. As currently crafted, it lowers standards for drug and device approvals and safety, and risks adding to the rising cost of prescription drugs.
The ostensible rationale for the legislation—being pushed by drug and device companies—is that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared with other countries.
