New FDA Directions, Part 2 – Cures Implementation

In Part 1 of FDA New Directions, we looked at the issue of pricing. Today we’re looking at implementation of the 21st Century Cures Act (the Act).

Prior to becoming the FDA Commissioner, Dr. Gottlieb was a strong supporter of the Act, signed into law by President Obama in December 2016. The legislation represents a significant bi-partisan effort and is a milestone in FDA authority and heralded by proponents as reforming the approval process to be more effective and patient-centric, among other things. As a nominee, Dr. Gottlieb expressed support for the Act’s timely implementation and has long been an advocate for some of its key provisions aimed at streamlining approval even before they were embodied in the legislation, perhaps most notably as an advocate for the use of adaptive clinical trials. Now as Commissioner Gottlieb, he is now in charge of the implementation of the Act.

It has been an oft-stated aim of this Administration to alleviate regulatory burdens on companies, especially those associated with bringing new medicines to market. The Act has a specific legislative aim to use multiple means of liberalizing standards for drug approval consideration and to include and involve the patient experience in assessing the efficacy of new drugs. While the Act enjoyed wide support in Congress, those who did not support it were concerned that safety standards could erode in favor of facilitating approval. However, prior…