Expectations that the 21st Century Cures Act would sail through the House this week hit a snag Wednesday night when the Rules Committee voted to include an amendment to switch the bill's funding from mandatory to discretionary.
The move is seen by supporters of the 21st Century Cures Act—which includes a wide array of provisions aimed at speeding medical innovation and regulatory approval—as a threat to the bipartisan support the legislation has enjoyed since it was introduced in May with 230 co-sponsors.
The bill is expected to go before the full House for a vote on Friday. If passed, it faces uncertain prospects in the Senate, though the White House expressed qualified support (PDF) Wednesday.
The funding amendment was introduced by Rep. David Brat (R-Va.), a fiscal conservative who said during the committee meeting that it was unacceptable to add to the $2.2 trillion in mandatory federal spending, which largely pays for Medicare, Medicaid and Social Security.
In a request for comment, Brat responded in an email on Thursday. He said though the 21st Century Cures Act makes “positive reforms” to get drugs and medical devices through the FDA review more quickly, he called the mandatory funding mechanism a “serious flaw” within the bill that he could not support.
“The federal government is not in a financial situation to support new programs without meaningful offsets of other spending,” Brat said. “The offsets for this new program are not the kind of true structural reforms that we need.”
The bill would provide an additional $8.75 billion in funding for the National Institutes of Health over the next five years, as well as $550 million in added funds for the Food and Drug Administration. Because of the mandatory spending mechanism, those funds would be guaranteed and not subject to yearly appropriation and authorization by Congress.
Making the funding discretionary would effectively kill the bill, a congressional staffer said.
Brat's amendment sets up a fight between some of the GOP's most fiscally conservative members and those who want to see the bill passed.
“When this bill becomes law, over the next five years the NIH and FDA will continue to receive the bulk of their funding through the regular annual appropriations process, with a temporary add-on to be allocated as mandatory spending by the Appropriations Committee,” House Energy and Commerce Committee Chair Rep. Fred Upton (R-Mich.) said in a statement in an effort to assuage concerns. “At the end of those five years, we believe America will have seen tremendous progress on the path to cures; at that time, the Innovation Fund will expire and these agencies will continue to be funded through the regular discretionary spending process.”
The bill's supporters point out that the costs associated with implementing the provisions of the Cures Act are temporary and paid for, largely through oil sales from the Strategic Petroleum Reserve. The Congressional Budget Office estimated the legislation would reduce federal spending by $470 million through 2025.
Trade groups representing the pharmaceutical drug and biotech industries said they oppose the Brat amendment, saying it undermines efforts to provide robust funding to the NIH.
Some of the bill's supporters point out that the same lawmakers opposing mandatory NIH spending voted last year in favor of $10 billion in mandatory spending for the Veterans Access, Choice and Accountability Act of 2014, which was intended to provide veterans better access to healthcare.
The 21st Century Cures bill is viewed by supporters as a way to expedite the process by which medications and medical devices are approved in order get new treatments to patients faster. Critics of the bill have argued it heightens the risk for harm to patients by loosening standards for approval.
