Supporters of the 21st Century Cures Act hope Congress can take advantage of its last chance to approve the legislation before the next administration, despite some recent calls for waiting to include language on prescription drug prices.
About a dozen patient advocacy and union groups said last week that the package of biomedical innovation bills that Senate Majority Leader Mitch McConnell said would be a priority in the lame-duck period after the presidential election should not be considered this session. They suggest the legislation be reworked to include provisions that address rising prescription drug prices.
Ellie Dehoney, vice president of policy and advocacy at Research America, said that while prescription costs are an important issue, it should be addressed in separate legislation so that the important bipartisan-backed provisions in the 21st Century Cures Act can be put into law. Waiting until the next administration and the next Congress could undo years of progress toward final passage.
Congress should not pass up the opportunity for innovation in favor of one-off policy making, Dehoney said.
"We don't have the luxury of time," she said. "If we can do this, do this. More talking about it doesn't serve a single patient."
Congress is slated to return Nov. 14 but will also have to work on year-end budget agreements before the next administration and Congress begin work next year.
Dehoney said she hopes Cures is attacked immediately when Congress returns in November so that it can be wrapped up before budget negotiations stall other work.
It's been more than a year since the bill easily passed the House. The Senate has approached the legislation differently, dividing it into about 20 separate bills. They were all approved by the Senate Health, Education, Labor and Pensions Committee, but they haven't been put on the floor for a full vote.
The main disagreement stalling passage of the legislation has been mandatory funding for the National Institutes of Health. The version that passed the House included more than $9 billion for NIH over the next five years. Some of that would go toward the Cancer Moonshot initiative spearheaded by Vice President Joe Biden.
Senate Republicans have balked at the mandatory funding and said the NIH should be required to restructure its budget before receiving more funds. Dehoney said there are indications the funding issue has been worked out, possibly with an amount for the NIH that is lower than in the House bill.
In addition to the funding to aid research at the NIH, the 21st Century Cures Act would improve health IT interoperability and make the clinical trials process and other research at the federal level more efficient. It would also create guidance for regulating products that are a combination of drugs and devices.