From the WSJ today:
New FDA Chief Wants to Fast-Track Some Drugs, Use More AI
Commissioner Marty Makary faces declining staff morale as he remakes agency
WASHINGTON—Embracing artificial intelligence. Taking on companies that make ultra-processed foods. And offering a fast-track to approve drugs the Trump administration views as a priority.
Welcome to the new Food and Drug Administration as envisioned by Dr. Marty Makary, who is leading the agency under Health Secretary Robert F. Kennedy Jr. Both men have said they want to overhaul the agency, citing what they see as the FDA’s reputation for coziness with pharmaceutical companies.
Makary’s goal is “to deliver more transparency, unleash innovation, eliminate conflicts and lower drug pricing,” said Calley Means, a White House adviser and ally of Makary’s.
The changes are coming so swiftly, and often without input from career scientists, that Makary faces declining staff morale threatening to stymie his efforts. He must also contend with the administration’s staff cuts at the FDA, which have been partly undone but shrank the workforce nonetheless. And critics say Makary is playing fast and loose with the FDA’s commitment to world-class science.
“Instead of gold-standard science, what I’m seeing is an effort to create a scientific record that supports a particular conclusion,” said Susan Mayne, a former head of a food safety division at the FDA.
The FDA regulates products that account for one-fifth of American consumer spending—everything from lettuce to vapes to pet vaccines. The former Johns Hopkins surgeon’s stewardship of the agency will be key to whether the Make America Healthy Again movement—championed by Kennedy and adopted by President Trump—can secure policy wins at the federal level. From his perch at the FDA, he will also influence the number of new treatments for sick Americans, the safety of the nation’s food supply and the country’s response to outbreaks such as bird flu or screwworm.
One of Makary’s new ideas is dubbed the “Commissioner’s National Priority Review Voucher,” which will allow him to promise frequent feedback and sped-up drug application reviews—within 30 days of a firm sending final data, compared with the typical 10 months now—to specially selected companies, according to a document viewed by The Wall Street Journal that outlines the proposed program. In a press release Tuesday after this article was published, the FDA said that the sped-up review would be one to two months, rather than 30 days.
Makary’s push for a nimbler agency that closely communicates with certain companies is at odds with past criticism from Kennedy and his supporters, who have lambasted the agency for its rapid approval of Covid-19 vaccines as part of Operation Warp Speed.
The FDA will give the vouchers to firms that “are aligned with the national health priorities” of addressing unmet public health needs, making drugs domestically to boost national security or making drugs more affordable in the U.S., according to the document, though it didn’t offer further detail. The agency could give the vouchers for specific products, or to companies to speed up the product approval of their choosing. The vouchers would be valid for two years and couldn’t be sold.
“To reinvigorate innovation, we must become a user-friendly FDA that partners with industry,” Makary wrote in the medical journal JAMA last week. “At the same time, the FDA will guard against a cozy relationship that has characterized the agency in the past.”
Congress has created past FDA voucher programs, but the FDA could create this program on its own, lawyers with expertise in drug law said. Still, rewarding companies who have lowered drug costs would be new territory for the agency, which has had little to do with drug prices.
“If this is able to incentivize research or work in certain significant priorities that otherwise would not be affordable or interest to manufacturers, that would be a significant win,” said Lowell Schiller, a former acting chief counsel at the FDA. “It would need to be a thorough review that doesn’t cut corners.”
Many FDA employees breathed a sigh of relief when Makary was nominated, grateful that in contrast to Kennedy, Makary came with impressive academic credentials. A cancer surgeon with an extensive research record, Makary had also studied public health at Harvard University and written about flaws in the U.S. healthcare system.
Makary took the helm at the FDA just as Kennedy carried out sweeping job cuts in the nation’s health agencies, including 3,500 cuts at the FDA, though some of those have now been walked back. Last week employees were once again able to access scientific journals that had been cut off during the Department of Government Efficiency’s cost-cutting.
But agency morale remains low, according to people inside and outside the agency. So many employees have recused themselves on industry matters—indicating that they are looking elsewhere for jobs—that it has been difficult to staff certain projects at the agency, according to people familiar with the matter. Former FDA Commissioner Scott Gottlieb said on CNBC in April that as many as 600 reviewers, or about a quarter of the review staff, had recused themselves.
“Recusals also occur to ensure staff not participate in engagements that have even the perception of a conflict of interest,” an FDA spokesman said.
Makary and his new vaccines chief cut career scientists out of the shaping of a new framework for approving Covid-19 vaccines that they unveiled in the New England Journal of Medicine in May, people familiar with the matter said.
The FDA’s new vaccines chief, Dr. Vinay Prasad, also overturned career staff advice when narrowing an approval for a Moderna vaccine, according to people familiar with the matter. Prasad called it a “small disagreement” in an internal email viewed by the Journal.
In the past FDA commissioners have rarely involved themselves in product decisions, careful to avoid the appearance that political appointees, not career staff, were making scientific judgments.
Some career leaders in the agency don’t have a working FDA email address for Makary, and say he must be approached through his handpicked office staff for official business, people familiar with the matter said.
Some employees remain hopeful that a new artificial-intelligence tool named Elsa, unveiled by Makary, will help product reviewers spot fake data. Currently the tool is clunky and gets basic facts wrong, people who have used it said.
“The errors were the result of users learning a new system and were not inherent to Elsa,” the FDA spokesman said.
An FDA official said about 6,000 people are using the tool weekly. AI can “modernize the FDA and radically increase efficiency in the review process,” Makary wrote in JAMA.
Makary is trying to cheer agency employees who have been a target of his boss. Kennedy posted on X in October that FDA employees should “pack your bags” and “preserve your records.”
Makary sends out selfie videos to the agency, urging employees to have good days, and circles the agency’s White Oak, Md., campus on foot, thanking workers.
Write to Liz Essley Whyte at liz.whyte@wsj.com |
