By their very nature, presidential transitions tend to be tumultuous affairs, especially when one party is taking the reins from another. That’s never been truer than this time around, with President-elect Donald Trump espousing his belief that many federal institutions are in need of serious overhaul—or outright elimination. His nominations for Health and Human Services, Labor, Energy, and the Environmental Protection Agency have track records suggesting they don’t like a lot of what’s going on at the agencies they may be taking over.
While Trump has not made an official choice to head the U.S. Food and Drug Administration (FDA) yet, news sources have placed Jim O’Neill at the top of the candidates list. An avowed Libertarian, he’s called for spiking the FDA’s charge to determine whether new medicines are effective before approving them for sale. “Let people start using them, at their own risk,” he said in a 2014 speech to a biotech group, as reported in STAT. O’Neill is managing director at Mithril Capital Management.
In the midst of this tsunami of change, the 21st Century Cures Act was passed by the House on November 30, by the Senate on December 6, and signed by President Obama on December 13. While it benefitted from a rare display of bipartisanship on Capitol Hill, some wonder if an incoming Trump will impact it in ways different than a President Hillary Clinton might have done. It provides $1 billion funding to combat the opioid epidemic in communities and invests $1.8 billion in new resources to support the current Vice President’s Cancer Moonshot project. It also it invests nearly $3 billion to continue subsidizing the work invested in the President’s BRAIN and Precision Medicine Initiatives over the next decade.
“With all my optimism, I hope we (research) fly under the radar as low/no priority for revamping,” says an Association of Clinical Research Professionals (ACRP) member who preferred to speak anonymously. The vast majority of other members we spoke with agree that the $64,000 question is whether the Act will come to fruition.
FDA brass has sung the praises of the Act. Chairman Robert Califf, MD, believes it will “support our efforts to modernize and improve efficiency in clinical trial design.”
ACRP Executive Director Jim Kremidas echoed Califf’s enthusiasm. “This is an important step in the right direction to further advance clinical trials,” he said.
Califf sees an opportunity to develop a common understanding of which trial designs should be used for which clinical issues. His example: “In cancer…we’re already weighing the use of common control trials, which share a control arm, involve multiple different drugs for the same indication, and may even involve different companies.”
Because this is Capitol Hill, the fate of the Act is by no means resolved. We’ll have to keep an eye on what happens after President Trump is inaugurated January 20.
Author: Michael Causey