By MATTHEW PERRONE
WASHINGTON (AP) — Weeks after ordering all Food and Drug Administration employees back into the office, the agency is reversing course, allowing some of its most prized staffers to work remotely amid worries that recent layoffs and resignations could jeopardize basic functions, like approving new medicines.
An internal email obtained by The Associated Press states that FDA leadership are “allowing review staff and supervisors to resume telework” at least two days a week. The policy shift was confirmed by three FDA staffers who spoke to the AP on the condition of anonymity to discuss internal agency matters.
The message was sent Tuesday to some of FDA’s hundreds of drug reviewers. Staffers said a similar policy was communicated to reviewers who handle vaccines, biotech drugs, medical devices and tobacco products although not necessarily in writing.
It’s the latest example of the Trump administration’s chaotic approach to overhauling the federal health workforce, which has included firings, a scramble to rehire some employees, and then additional layoffs last week of an estimated 3,400 staffers, or more than 15% of the agency’s workforce. When FDA employees were called back to the agency’s headquarters last month they confronted overflowing parking lots, crowded offices and broken or missing supplies.
A spokeswoman for Health Secretary Robert F. Kennedy Jr. said the administration is returning to “pre-COVID telework arrangements for reviewers, whose read and write work output is tracked in 15-minute increments to ensure productivity and accountability.”
While many agencies switched to telework during the pandemic, the FDA began embracing the practice a decade earlier. The flexibility was seen as a competitive perk for recruiting employees who can often earn more working in industry.
Last week’s cuts included entire offices focusing on FDA policy and regulations, most of the agency’s communication staff and teams that support food inspectors and investigators. Senior officials overseeing tobacco, new drugs, vaccines and other products have also been dismissed or forced to resign. Staffers have described rank-and-file employees “pouring” out of the agency.
Former FDA Commissioner Dr. David Kessler called the cuts “devastating, haphazard, thoughtless and chaotic” during a House hearing on Wednesday.
When Kennedy announced plans to eliminate 10,000 staffers across the federal health workforce, he noted out that FDA medical reviewers and safety inspectors wouldn’t be impacted.
In February, HHS was forced to recall some probationary employees who were fired, including hundreds of medical reviewers at FDA, who are largely funded by industry fees, not federal dollars.
But last week’s cuts combined with resignations and retirements have raised a new threat: that FDA funding could fall so low that it short circuits a long-standing system in which companies help fund much of the agency’s operations.
Nearly half the FDA’s $7 billion budget comes from fees collected from drug, device and tobacco companies. The agency uses the money to hire thousands of staffers to quickly and efficiently review new products. For example, about 70% of the FDA’s drug program is financed by user-fee agreements, which must be reauthorized by Congress every five years.
But the agreements stipulate that if FDA’s federal funding falls below set levels, companies are no longer required to pay and, in some cases, can claw back their money. The threshold requirements are designed to ensure Congress continues funding FDA, rather than relying entirely on the private sector.
FDA and industry groups are supposed to begin negotiations later this year to renew several user-fee agreements, including those for drugs and devices.
“I don’t think the agency nor regulated industry can afford for ‘user fees’ not to be reauthorized,” said Michael Gaba, an attorney who advises FDA-regulated companies.
Whatever the reasoning behind the telework shift, former federal officials say it’s a sign that recently confirmed FDA Commissioner Marty Makary is trying to retain and rebuild agency staffing. Makary made his first appearance at FDA’s headquarters last Wednesday, one day after the mass layoffs. According to the memo obtained by the AP, Makary signed off on the return to telework for some employees.
“Dr. Makary needs to rebuild teams and restart the engine of productivity lost to weeks of job insecurity, uncertainty and shortages of team members,” said Steven Grossman, a former HHS official. “Turning commuting time back into work time is a great first step in achieving both.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Originally Published:
Source: Paradise Post
