Manufacturers count on faster product approvals under Cures Act
2017will be a year of challenge and opportunity for the pharmaceutical and medical device industries thanks to the 21st Century Cures Act, which passed with their vigorous lobbying support.
The law promises $500 million in new funding for the Food and Drug Administration over the next 10 years to speed up product approvals, including expedited processes for innovative drugs and devices or products that serve a rare need.
The legislation likely will spur regulators to look beyond the lengthy, costly clinical trials that define the current approval process, said David Rosen, a former FDA official who now heads the FDA practice group at law firm Foley & Lardner. The law calls for regulators to give more weight to patient input and data that reflects the experience of patients in realworld settings.
Whether the FDA actually will be able to speed up approvals depends on the success of its leaders in bolstering the agency’s infrastructure and workforce, said Marc Scheineson, another former FDA official who heads Alston & Bird’s food and drug practice. Agency leaders have noted the difficulty of attracting qualified staff; there is a large backlog of unfilled positions.
Although regulators will be busy in the coming year implementing the law, there likely won’t be any noticeable changes to FDA processes in 2017, Scheineson said. But the industry is likely to see a jump in product approvals over the next five years, he said. The FDA has approved only 19 new medicines so far in 2016, down from 45 in 2015 and 41 in 2014.
Implementation of the law may be influenced by whom President-elect Donald Trump chooses to lead the FDA. Per protocol, Dr. Robert Califf, the current commissioner, will offer his resignation. Jim O’Neill, a venture capitalist and former HHS official, and Dr. Scott Gottlieb, a former FDA deputy commissioner, reportedly are under consideration for the job.
O’Neill previously has said he would like the FDA to focus on making sure new drugs are safe while paying less attention to effectiveness.
Rosen expressed concern about having a commissioner who’s not a physician or scientist. “I think you really need to understand the underlying medical aspects of these situations to fully understand the decisionmaking in the approval process,” he said.