Congressional Republicans are plotting an ambitious health policy agenda for 2017, but lawmakers will still have to reauthorize the Food and Drug Administration user fee program for speeding along new drug and device approvals.
Some experts who have worked in drug policy say the passage of the 21st Century Cures Act earlier this month could ease that process, as many of the policies that could have been proposed to pass alongside the reauthorization are now law.
The user fee program collects money from pharmaceutical companies, medical device makers and generic drug makers to help fund the Food and Drug Administration’s review process. The current program expires in October. If it isn’t reauthorized, FDA approval for new products could grind to a halt.
Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner during the George W. Bush administration, said the newly-signed Cures law and the PDUFA deal between industry and the FDA agree on “the importance of value of real world evidence.”
Pitts said there’s also a shared belief in Cures and the FDA and industry agreement that “various expedited review pathways should be used more aggressively,” he told Morning Consult.
“The goal here isn’t to bring drugs to market more quickly, the goal is to bring drugs to market more quickly with a heightened degree of safety and efficacy,” he said.
Kathleen Weldon Tregoning, senior vice president for corporate affairs at Biogen, agreed that passage of Cures could mean fewer policy fights on user fees next year.
“As we look at PDUFA, we want to continue the steady progress of how do we continue to advance our regulatory capabilities to address the rapidly accelerating pace of science,” she said last week at the FDA/CMS Summit in D.C. “I would expect that to continue and advance.”
Sen. Lamar Alexander (R-Tenn.), chairman of the Health, Education, Labor and Pensions Committee, which has jurisdiction over user fees, said this month he sees reauthorization as a chance for bipartisan work next year.
Even so, the user fee legislation could still see policy debates. Democrats are expected to bring up drug pricing issues in hearings on user fees next year. While some Republicans have shown an appetite to address the drug cost fight, it’s far from certain anything would be added to a final agreement.
Allan Coukell, senior director for health programs at the Pew Charitable Trusts, said adding fees to improve FDA regulation of over-the-counter drugs could be another add-on to the agreement.
Another quirk in this year’s process is that the Obama administration, which negotiated the agreement with the industry and public stakeholders, will be leaving office as Congress begins the negotiation process. That likely won’t create any pitfalls, experts say.
The current agreement between the FDA and the industry members is a “good document” with bipartisan support, Pitts, the former FDA official, said. The agreement is created after months of negotiations and public meetings.
The pending deadline also could deter a new administration from revising the agreement, Coukell said.
“If the user fees aren’t reauthorized, pink slips go out to the FDA and a whole lot of the review process stops, and so there certainly would be a lot of pressure not to take months doing something that would restart that process,” he said.