Washington, DC ― Sheila Kaplan reports on STAT the United States 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, in July 2015.
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, in July 2015.
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.
For Kaplan’s full STAT story, click here.
Follow Kaplan on Twitter @BySheilaKaplan.
Follow STAT — which reports from the frontiers of health and medicine — on Twitter @statnews.
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.
For Kaplan’s full STAT story, click here.
Follow Kaplan on Twitter @BySheilaKaplan.
Follow STAT — which reports from the frontiers of health and medicine — on Twitter @statnews.
