21st Century Cures Passes House -- with Pros and Cons

For those returning to their jobs on the Monday after Thanksgiving, there was a surprise. A compromise version of 21st Century Cures legislation had been crafted and was now moving forward through the legislative process. It overwhelmingly passed the House and is expected to pass the Senate next week, despite opposition from some Democratic Senators.The legislation is nearly 1000 pages long and combines some (but not all) of the original House Cures legislation, along with mental health and opioid legislation and a number of changes to Medicare and Medicaid payment rules. The $6.3 billion legislation is fully paid for by sales of strategic petroleum reserves, transferring money from the ACA’s public health and emergency fund, and a handful of smaller provisions that generate budgetary savings.The bill creates an FDA Innovation Account to pay for the myriad new activities that will be required of FDA under the 21st Century Cures legislation. Over a 10-year period, the account will receive $500 million, starting with $20 million in FY 17 (the current year) and ending with $55 million in FY 25. Click here to review the allocation by year. The funds will be set aside solely for FDA’s use to carry out Cures-generated responsibilities, and will not count against the budget ceilings that otherwise restrict the growth in non-defense discretionary programs. Nonetheless, the monies will need to be appropriated from the Account; otherwise FDA does not receive the funding. There is no guarantee that the appropriations committees will choose to appropriate these monies or that they will increase the funding available to FDA.This adds a new dimension to our yearly efforts to increase the budget authority funding available to FDA. The appropriations committees can treat the FDA Innovation Account as additional monies to carry out new responsibilities, which is how they are intended. However, nothing prevents the committees from using these funds to offset an equal number of dollars from the FDA’s BA funding base. In effect, this would require FDA to absorb the entire cost of Cures activities from existing funds and thereby deprive some existing programs of the funding that supports them.Even with the additional funds, the gap between FDA funding and FDA responsibilities is likely to grow larger with the passage of Cures. The agency will need the Cures funding and more to carry out its mission in both food safety and medical products. As we prepare for the FY 18 appropriation advocacy cycle, which begins in January, it will be even more important that we advocate for increased BA funding and that all FDA stakeholders join in this effort.Note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.