The push for increased funding for medical research at NIH is a rare area of bipartisan consensus, but the budget caps put in place in 2011 had posed an obstacle. The agreement sealed late last month, which lifted the cap for domestic spending by $40 billion over the next two years, is providing a new ray of hope.
Even before the caps were lifted, the proposed House spending bill included $1 billion more for NIH; the Senate bill had $2 billion more.
“I think it should be a good year for the NIH, because any of these numbers are an improvement,” said Rep. Tom Cole (R-Okla.), chairman of the Appropriations health subcommittee.
NIH officials have decried that their budget has stayed mostly flat since 2003, and has not kept up with inflation.
While advocates are broadly happy with the budget agreement, they are not entirely satisfied. The appropriations bill will only cover one year, and backers argue that a multi-year funding commitment would give NIH more certainty.
That commitment could come from a bill known as 21st Century Cures. It passed the House in July on a strong bipartisan vote and included $8.75 billion over five years in new funding for NIH.
The new money also came in the form of mandatory funding, meaning it is guaranteed and not subject to the annual appropriations process, a key feature for Democrats.
There is some question, though, over whether the Senate version of the bill will also have mandatory NIH funding. Some conservative Republicans object to adding new mandatory spending since they fear it accelerates spiraling debt.
Sen. Lamar AlexanderLamar AlexanderGroups warn of rural health 'crisis' under ObamaCare repeal Trump’s Army pick faces tough confirmation fight Trump faces risky ObamaCare choice MORE (R-Tenn.), chairman of the Senate health committee, and Sen. Patty MurrayPatty MurrayWeek ahead: Senate panel to vote on Trump's FDA pick Overnight Healthcare: GOP healthcare talks stall | Ryan takes backset to Pence in new repeal effort | FDA nominee grilled over industry ties Senators battle over FDA nominee's financial ties MORE (D-Wash.), the committee’s top Democrat, are currently in negotiations over the bill.
Murray has made her support for the measure contingent on having mandatory NIH funding.
Alexander says that he is open to mandatory funding, but only under certain conditions.
Asked if the new breathing room in the budget deal affects whether the innovation bill’s funding will be mandatory, Alexander said, “Not necessarily.”
“I think to have mandatory funding, first it ought to replace other mandatory funding, and second it ought to be for specific, limited purposes, and not compete with normal discretionary funding,” Alexander added.
Alexander’s suggestion to cut other mandatory funding to make room for NIH funds could prove problematic for some Democrats.
How to pay for the new spending is one of the biggest questions facing the bill. Other recent measures have scooped up many offsets that might otherwise have been used.
For example, the House version of the bill paid for $5.4 billion of its NIH spending through selling oil from the Strategic Petroleum Reserve, but that idea was snatched up to help fund the budget deal.
Finding ways to pay for as much funding as in the House bill could be a challenge.
Murray says she is still pushing on the issue of mandatory funding.
“This is all under discussion right now,” she said. “I believe we need mandatory NIH funding, the House had it in their bill. We've got a lot of work ahead of us.”
Indeed, while some House conservatives voted against the bill because of the mandatory funding, the opposition was not strong enough to prevent a bipartisan vote of 344-77.
Another thorny issue comes from the idea of speeding up the Food and Drug Administration’s approvals of new treatments.
The House version of the bill sought to accelerate approvals in part by encouraging the use of “real world” observational effects of a drug rather than more rigorous clinical trials. It also encouraged the use of preliminary measures known as biomarkers instead of waiting for the definitive results of a trial.
Some consumer groups and outside experts warned that the bill would lower the FDA’s standards to the benefit of pharmaceutical companies, who have been facing an onslaught of negative attention in the time since the House bill passed.
Murray has been clear that she wants to uphold the FDA as the world’s “gold standard” for ensuring safety.
The Senate version of the bill is expected to be narrower than the House version, focusing on areas of consensus. That could then be added on through the amendment process.
“The draft will be a starting point and we expect a robust amendment process in committee and on floor to add other priorities for both GOP and Dems,” said a Republican aide.
The amendment process could be risky, though, by opening the process up to politically treacherous issues.
The office of Rep. Diana DeGette (D-Colo.), the lead Democrat on the House version of the bill, is hopeful that a Senate bill will be released in the next few weeks. DeGette has been meeting with Senate Democrats and has seen positive signs.
Aside from the Senate innovation bill, the budget process is already something of a win for NIH.
Senate Democratic Leader Harry Reid (Nev.) said at a press conference late last month, after the budget deal was reached, that he had met with the NIH director and an official from Johns Hopkins University.
“They are elated that they think that we're going to be able to help fund the NIH at a reasonable number and give them a small increase,” Reid said. “We believe we can do that.”