NIH fight threatens medical reforms

The Senate is struggling to find a path forward on a medical innovation bill that could be crucial for White House priorities such as the “moonshot” to cure cancer.

The bill is being held up by disagreements over funding for medical research at the National Institutes of Health (NIH).

{mosads}Democrats say they will block passage of any bill that does not include new mandatory funding for the NIH, meaning it would be guaranteed and not subject to the annual appropriations process. They want Republicans to commit to a specific dollar amount before the bill reaches the Senate floor.

While medical research attracts bipartisan support, Republicans are leery of locking in new mandatory funding and want the costs to be offset.

An important development came Wednesday, when Sen. Lamar Alexander (R-Tenn.), chairman of the Health Committee, said he is willing to work with the ranking member, Sen. Patty Murray (D-Wash.), to reach an agreement on the bill’s funding.

“We’ll have to have an agreement on first, what we want do with the money; second, on a dollar amount; and third, on how we pay for it,” Alexander told reporters Wednesday. “And Sen. Murray and I and others will have to come to a consensus around that, and we’ll have to have that figured out before we can finish our work on the bill.”

Alexander indicated that the NIH funding could move alongside the roughly 50 proposals the committee is considering in the package, which is intended to speed up the Food and Drug Administration’s approval process for new drugs and devices.

“I’d like to take to Sen. McConnell a consensus on the 50 ideas that we have here and the consensus on a surge of funding for the National Institutes of Health at the same time and present them to him and say, ‘There it is, it’s bipartisan. It’s sufficiently bipartisan that you can put it on the floor,’ ” Alexander said, referring to Senate Majority Leader Mitch McConnell (R-Ky.).

Still, while there might be more agreement on the process going forward, finding a deal won’t be easy.

Republicans are divided on the issue. While Alexander says he is open to mandatory funding if it is targeted to specific areas like the cancer moonshot and precision medicine, Sen. Richard Burr (R-N.C.), another member of the committee and a leading Republican voice on healthcare, told The Hill that he opposes making the funding mandatory.

“I didn’t hear any encouraging signs,” Burr said Wednesday after a committee markup on some of the FDA reforms that could be included in the package.

He noted that Democrats are adamant that mandatory funding be part of the bill.

“I don’t see a real pathway to passage of an innovation bill,” he said.

Sen. Elizabeth Warren (D-Mass.) has been leading the charge for new funding, along with Murray, proposing to provide an additional $5 billion per year to the NIH. 

“Medical research costs money, and so far Senate Republicans have not put a single proposal on the table to provide the kind of robust, guaranteed, new money that NIH so desperately needs,” Warren said at the markup Wednesday. 

Finding a way to pay for new NIH funding is also proving difficult. There are few budgetary offsets within the Health Committee’s jurisdiction, forcing senators to look elsewhere.

The White House has been pushing Vice President Biden’s cancer moonshot and President Obama’s Precision Medicine Initiative, which involves using genome data from 1 million volunteers to help develop cures that are tailored to individuals. 

Those initiatives are unlikely to get off the ground unless the innovation bill passes Congress.

Alexander is stressing this point as he tries to build momentum for a deal. “I do not know of another way this year to get support for the president’s Precision Medicine Initiative or support for the cancer moonshot or a surge for mandatory funding for the National Institutes of Health unless we act on this bill,” he said.

Alexander met one-on-one with Obama on Feb. 25 after a precision medicine event at the White House. He said he told Obama he would do his “best to fully support” the two initiatives.

The White House, though, is staying quiet on the level of funding it wants. Asked on Wednesday whether the administration supports the push by Warren and other Democrats for $5 billion per year in NIH funding, White House officials declined to comment. 

In addition to the NIH funding disputes, there are also issues to be worked out over the FDA reforms, which some Democrats worry could speed up the process too much and lower safety standards. Democrats also want new funding for the FDA, which so far has not been welcomed by Republicans. 

The Senate’s bill would be its version of the 21st Century Cures Act, which passed the House on a bipartisan vote in July. House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) has made the bill his signature issue and has tried to use the White House push for the cancer moonshot to jump-start a Senate process that has gone far slower than he hoped. 

Alexander says he wants the effort to get to the floor by mid-April, when consideration of appropriations bills could start eating up floor time. Some lobbyists are skeptical that any deal can come together beyond a few minor, noncontroversial FDA measures. 

Upton released a statement Wednesday with his partner in the effort, Rep. Diana DeGette (D-Colo.), praising the Senate for moving forward with another round of FDA bills. 

“There is no better time or vehicle to advance the administration’s Precision Medicine Initiative and cancer moonshot,” they said.