Congress Shouldn’t Pass The 21st Century Cures Act In A Summer Rush

The full Senate may in the next few days consider companion legislation to the 21st Century Cures Act that passed the House last year. The legislation—currently 19 separate bills—makes substantial changes to the way the Food and Drug Administration (FDA) approves drugs and devices. Set to adjourn for an extended election-year summer recess on July 15, the clock is ticking. The congressional calendar in the fall is full and the Senate may simply not have the time to take up the complex legislation, and reconcile it with the House version, before the November elections. We believe that’s a good thing. The legislation, while containing some useful measures, is flawed. Instead of hastily agreeing to it, Congress should postpone consideration until 2017 and attach the best of the 19 bills (see below) to must-pass legislation on FDA funding through industry user fees. At that time, we believe the Senate should reject those bills that lower standards for drug and device approvals and safety, and risk adding to the rising cost of prescription drugs. This is a story two years in the making. Proponents of the proposed legislation—drug and device companies, and members of both parties in the House and Senate—argue that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared to other countries. That premise is faulty. Nearly two-thirds of the novel drugs approved in 2015, for example—29 of 45, 64 percent —...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Technology Featured Public Health Quality 21st Century Cures Act Congress FDA NIH regulation Source Type: blogs