ASHINGTON — It may be now or never for a landmark legislative push to speed up the US drug approval process — but there are signs that lawmakers just might make it work.
In the next four weeks, the Senate will either reach a compromise on a package to accelerate the approval of new medical cures, and to boost federal research funding, or run out of time and leave the work to the next Congress.
Congressional aides and medical research advocates say they are hopeful that Senate Republicans and Democrats can work out remaining disagreements about the legislation, mostly about funding, and bring it to the floor by next month.
If lawmakers fail, however, the chances that the Senate will vote on a bill will shrink considerably. Congress leaves for an extended summer recess on July 15, and by the time lawmakers get back in early September, they are expected to be preoccupied with bills to fund the federal government, with little to no time to work on other major legislation.
The House passed its version of the so-called 21st Century Cures Act last year. The bill, supported by the pharmaceutical and medical device industries as well as patient advocacy groups, would try to make it easier to get drugs and medical devices through the regulatory process and into patients’ hands. Critics, however, have argued that the legislation would undermine the Food and Drug Administration and government regulations meant to ensure patient safety.
Supporters are stressing the importance of a deal now.
“The Cures package is the best near-term opportunity for getting the increase in resources that we’re going to need” for the most promising new areas of cancer research, said David Pugach, president of the United for Medical Research coalition and a top lobbyist at the American Cancer Society Cancer Action Network.
Lawmakers have already come a long way. The House passed its version last summer in a lopsided, bipartisan vote. In the Senate, Tennessee Republican Lamar Alexander, the chairman of the Senate health committee, has taken a different approach, breaking up the Senate’s legislation into a series of smaller, pureed bills on narrow topics.
Even so, his committee has now passed 19 bills, covering issues like faster approval of “breakthrough” medical devices, therapies for rare diseases, and strategic plans for the National Institutes of Health.
But Alexander has said his ability to stitch them together and bring a package to the Senate floor depends on his ability to reach a funding agreement with the Democrats — which has yet to happen, even after months of discussions.
“What’s at stake is 2 1/2 years of thoughtful, deliberative dialogue across the country and across constituencies” about how to modernize the federal government’s approach to regulating innovative medical treatments, said Dr. Andrew von Eschenbach, a former Food and Drug Administration commissioner under President George W. Bush and a vocal supporter of the cures bills.
“If we don’t do this now, we’ve got to start all over again next year. All of this goes away,” he said. “Is this important? It’s unbelievably important.”
The big problem right now is how to pay for the billions of dollars of medical research funding that would accompany the policy changes. The committee’s top Democrats, including Senator Patty Murray of Washington and Senator Elizabeth Warren of Massachusetts, wanted it to be “mandatory” funding so it wouldn’t have to comply with the spending limits in federal law. Republicans have resisted that approach, and want to make sure Congress pays for any new funding by cutting spending somewhere else.
Alexander’s solution, which he has been trying to sell to the Democrats, is to approve a temporary “surge” of mandatory funding, not a permanent increase, and to pay for it with other budget cuts. So right now, aides said, the hunt is on for ways to pay for the new funding. A Senate Democratic aide involved in the effort said the only major sticking points are the size of the increase and how to pay for it.
“The policies have been worked out. There aren’t any kinks there. But they really have not come up with a number” or ways to pay for the funding increase, said Eleanor Dehoney, vice president for policy and advocacy at Research!America, a group that pushes for increased medical research funding.
Despite the challenges, and the tight window to reach a solution, there are signs that it’s too early to write off the chances of a Senate agreement. Alexander and Murray have a history of working together on significant bipartisan legislation. They were the main Senate authors of last year’s rewrite of the No Child Left Behind education law, an effort that also had to overcome difficult partisan disagreements.
They’re not giving up on an agreement. Margaret Atkinson, a spokeswoman for Alexander, said the senator “believes there is no reason to waste this opportunity to get a result for millions of Americans.”
And Murray, in a statement, said she was “very hopeful that we’ll be able to reach a bipartisan result in the coming weeks.”
There’s also a notable absence of the kind of public bickering that tends to happen when a congressional negotiation isn’t going well.
Medical research and disease groups say they’re hoping that the effort — a rare example of Republicans and Democrats working together at a time of bickering and dysfunction — doesn’t fall apart because of last-minute disagreements.
“They went though one of the most inclusive processes I’ve ever seen Congress do. They went to great lengths to solicit input even before they put a draft together,” David Arons, chief executive officer of the National Brain Tumor Society, said of the public forums the House sponsors held two years ago to launch the initiative.
“To come this far, in this kind of congressional environment, and not get this worked out would be a real shame,” Arons said.