Trump ‘Wild Card’ in Drug Price Debate: Attorney
Attorney Al Cacozza (Ropes & Gray) says in a year-end podcast on coming changes to FDA that President-elect Donald Trump is a “big wild card” in the public policy debate over drug pricing. “On the campaign trail,” Cacozza says, “he railed against high drug prices, and vowed to use his negotiation skills to drive them down. Since the election, he has publicly chastised several large companies, so far in the defense sector, over high costs for certain government contracts. So it is possible he may use the bully pulpit to criticize certain high drug prices, and he will have support from a bipartisan group of legislators…. My guess is that industry will seek to temper its high-profile pricing increases in an attempt to respond to these public concerns. We have already seen several drug companies announce voluntary price restraints. In the end … I would be very surprised to see any formal systemic effort to control drug prices.”
Cacozza identified three other issues of particular interest to drug and medical device manufacturers: changes at FDA with the new administration, implementation of the 21st Century Cures Act, and reauthorization of the user fee act.
He said that as it implements the Cures Act, FDA will be looking to incorporate patient views in the design of clinical trials, and should be more open to patient-reported outcomes data in a drug marketing application. “While the overall evidence standard remains unchanged,” he said, “the law does call for FDA to consider real-world evidence in an application for a new use for an approved product. We will have to see how that affects approvals going forward.”
The new administration has said little about FDA, Cacozza said, either during the campaign or after the election and there’s been no indication who a new FDA commissioner may be. “The general philosophy of the new administration has been to reduce regulation,” he said. “So while there may be some pressure on FDA in this regard, it is unclear what it will mean in practice. It could be simply an extension of the provisions of the Cures law to open up the type of evidence that FDA will consider in making its risk benefit assessment based on the traditional substantial evidence standard. It could be a resolution of the long-standing debate about the limits on manufacturer speech shifting toward a First Amendment-friendly approach that allows for dissemination of truthful, non-misleading information even about off-label uses. At its most radical it could be an effort to scale back the efficacy requirement that was adopted by law in 1962.”
Finally, he said, because user fees are now part of the fabric of the agency budget, reauthorization has been considered a mandatory enactment, which opens up the bill to be a “Christmas tree” on which members of Congress hang all sorts of FDA measures. “By the time the user fee bill is up for final consideration, likely in the third quarter of the year,” Cacozza said, “we will see what issues have percolated to the top of the agenda.”