21st Century Cures: A Good Start Was Essential

Representative Bobby Rush (D, IL) called the H.R. 6 mark-up “a lovefest.” Representative Joe Barton (R, TX) couldn’t recollect another major piece of legislation reported unanimously from the E&C Committee (it passed 51-0). Chairman Upton (R, MI) emphasized that the bill contained contributions from most committee members.It was also a banner day for the Alliance and all advocates for additional resources for FDA. That possibility emerged on Wednesday, according to The Hill newspaper, when Chairman Upton, told reporters:

We could simply just raise the authorization level but there’s no guarantee the appropriators will ever spend it. So what we have to do is create a fund in essence from mandatory spending cuts.

This was exactly the type of commitment that the Alliance asked for as part of last week’s Analysis and Commentary, when we argued that “additional work and additional resources must go hand-in-hand.”We have no position on the substance of H.R. 6 -- our members represent too many diverse viewpoints and our mission extends only to FDA resources -- but we are united in our belief that funding must be part of the conversation when new responsibilities are added to the agency. So, what emerged at mark-up -- $550 million over 5 years to carry out six new areas of FDA responsibility* -- represents an unprecedented commitment by an authorizing committee. This commitment addresses the risk that a set of new mandates without resources could inadvertently supplant critical FDA activities and processes. We encourage Alliance members to contact House Energy and Commerce Committee members to express your appreciation for their support of resources for FDA.Based on questions I received from both Alliance members and media, there is a misunderstanding about the difference between the FDA estimates of the cost of responsibilities under H.R. 6 and what the committee has provided in the Cures (FDA) Innovation Fund (about half of the FDA estimate). Actually, there is no inconsistency because the mandatory monies are only for specified purposes.* Other new FDA responsibilities in H.R. 6 and appearing in FDA’s cost analysis may form the basis of additional appropriations requests.This is parallel with the committee’s treatment of NIH. Some of the NIH’s needs are met by the mandatory NIH Innovation Fund and other responsibilities are encouraged to be met from an increase in authorized appropriations. FDA’s appropriation is, in effect, a permanent authorization at the level of “such sums as may be necessary,” so there is no equivalent need to explicitly authorize additional funds for them to appropriated to FDA.Should H.R. 6 become law, it would be the Alliance’s job to lead the effort for additional funding for some of the costs to implement the legislation. Note that given the timeframe for passage of the legislation, this would be the FY 17 cycle (next year), not the current one.What happens next? H.R. 6 will be available for 30 days before it comes to the House floor. This time allows other committees to decide if they wish to formally review and possibly mark-up the legislation. If there is a House vote in late June or July, the bill would go to the Senate. The Senate already has its own version of 21st Century Cures underway, albeit on a slower timeframe. Most likely, the bills will meet up in the Winter to resolve differences between the House and Senate versions. As with any piece of legislation, a good start is essential but may or may not create enough momentum for a new law to be enacted.—–* The specified responsibilities that would be paid for by the Cures (FDA) Innovation Fund include development of data on natural history of diseases; support for the Council for 21st Century Cures; development and use of patient experience data to enhance structured risk benefit assessment framework; qualification of drug development tools); utilizing evidence from clinical experience; and grants for studying the process of continuous drug manufacturing.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.