WASHINGTON — The Senate’s plan to speed new drugs and medical devices to market just hit an unexpected roadblock: President-elect Donald Trump.
Lawmakers have spent months negotiating a package of bills that would clear the path for a major shift in the way the country regulates prescription drugs and medical devices — one meant to help spur innovation in health care.
In exchange for simplifying the regulatory process, a top priority for Republicans, Democrats would secure additional funding for the Food and Drug Administration and the National Institutes of Health.
But after months of hearings, negotiations, and, finally, an agreement that landmark legislation might be approved in a lame-duck session, lobbyists and congressional aides say the deal will likely unravel — leaving unclear what happens in the next Congress.
The House already passed its version of the legislation, the 21st Century Cures Act, last year.
But Senate Democrats, who worked with the GOP to develop a package of 19 “medical innovation bills” as companion legislation, have always had qualms about the easing of FDA regulations they see as essential to ensuring consumer safety.
Although Trump has said little about FDA matters, he has railed against government regulations broadly.
That is leaving the Democrats loathe to give the FDA marching orders to do more, and faster, if the Trump administration will find other ways to eliminate regulations.
But the politics are difficult.
Democrats have long advocated for additional funding for two of President Obama’s marquee science initiatives: the “moonshot” against cancer, being led by Vice President Biden, and the Precision Medicine Initiative. Both of those initiatives would likely suffer without funding that was to be included in a 21st Century Cures package.
One pharmaceutical industry lobbyist, who spoke on condition of anonymity to speak candidly, said, “I think the choice for Democrats depends on how much they want to secure funding for the cancer moonshot [and the] Precision Medicine Initiative.”
It would be tough to cite any legislation that lawmakers have devoted more time to this session than this cures proposal.
Senator Lamar Alexander (R-Tenn.), the chairman of the Committee on Health, Education, Labor, and Pensions, was determined to find a way to provide “surge” funding that would be palatable to his GOP colleagues. Alexander repeatedly called the package the most important legacy the outgoing Congress could leave behind.
Over the last congressional recess, both Democrats and Republicans hinted that they were coming closer to an agreement that could be approved in the final weeks of the lame duck Congress.
Even before Trump’s victory, however, Democrats on the House Energy and Commerce Committee announced that they wouldn’t back a bill unless it included provisions to make medicines more affordable. Next, a group of left-leaning consumer groups, unions, and the Center for American Progress urged Congress to take no action on the legislation until next year — to give the lawmakers time to develop a measure to lower prescription drug prices.
Advocacy groups seemed flummoxed over the fate of the legislation now.
“The truth of the matter is everyone’s calculation is going to change,” said David Pugach, vice president of federal relations for the American Cancer Society Cancer Action Network. “Whatever anyone was thinking last night, it’s different today.”
“There are some people who may be fearful of the impact of the bill, as a result of the election,” Pugach said, “but I also think there’s some people who may view this as being still a good opportunity, missed if we delay until next year. With a new administration comes new priorities, and circumstances could very easily overtake this bill and the promise it has to deliver new and better therapies for cancer patients and others.”
Senate Majority Leader Mitch McConnell said Wednesday that he had two priorities for the lame-duck session: funding the government and passing 21st Century Cures. But many observers say it’s too late.
Former FDA Commissioner Mark McClellan, now director of the Margolis Center for Health Policy at Duke University, said the legislation still has a chance of passage.
“It’s become pretty strongly bipartisan,” McClellan said. “Still, you never know, in a lame-duck session, until you get there.”
If it fails, he said, then key measures could be attached to the Prescription Drug User Fee Act, an FDA-funding measure that must be approved next year.