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 to the approval of his nomination and afterwards, Commissioner Gottlieb has maintained that the Act will result in drug development that is more patient-centered and efficient while at the same time maintaining the gold standard of FDA.

Implementation of the Act – which runs nearly 1,000 pages – will not be overnight, but the mechanics of implementation – and the means for following it – have begun. In a July 7 blog posting Commissioner Gottlieb announced a “detailed work plan” to outline steps to implement the Act and that an intra-agency Cures Steering Committee had been formed to coordinate implementation across FDA. Also in July , FDA published an initial list of deliverables under the Act which is designed to morph into a tracking tool by which progress can be ascertained. This provides a central place to see all of the moving parts involved in implentation, though as a tracking tool it could stand to be made a bit more user-friendly.

Also in his July 7 blog posting, Commissioner Gottlieb outlines activities for implementation under FDA’s various centers – CBER, CDER, and CDRH.

And speaking of CDRH, in a blog posting in June, Commissioner Gottlieb called out the importance of the work FDA is doing in relation to the digital health provisions of the Act and stated that FDA would be providing additional clarification related to what falls outside the scope of FDA regulation and to make clear the agency’s position on products containing multiple software functions – components of which may be under FDA regulation and containing some that may not. Perhaps indicating a more flexible approach to the regulation of digital health, he stated that the agency will be devoting resources to “higher risk priorities” and discussed the creation of a possible third party certification program for low risk products to be marketed without FDA review.

As Dr. Gottlieb, he made clear that he has favored streamlined approaches to regulation – both in terms of less regulation and in focusing resources on areas where risk of harm is higher – as FDA Commissioner Gottlieb it seems equally clear that he meant what he said.

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