FDA reverses course on telework after layoffs and resignations threaten basic operations

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FDA reverses course on telework after layoffs and resignations threaten basic operations
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WASHINGTON (AP) — Weeks after ordering Food and Drug Administration employees back into the office, the agency is reversing course, allowing some of its most

FILE - The U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md, Thursday, Aug. 2, 2018. WASHINGTON — Weeks after ordering 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 and medical devices, 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. 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 lower level employees as “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 Health Secretary Robert F. Kennedy Jr. 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. HHS did not immediately respond to a request for comment Wednesday evening. 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 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 CommissionerMarty 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. “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.A Missouri foster mother has been charged with child abuse and endangerment as authorities investigate whether she traded an adopted daughter to someone in Texas for a monkey and mistreated other children in her care. The 70-year-old woman from Winfield has been jailed on $250,000 bond since her arrest over the weekend, with her next WASHINGTON — Weeks after ordering 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 FORT LAUDERDALE, Fla. — U.S. Attorney General Pam Bondi on Wednesday announced the seizure of roughly $510 million worth of illegal narcotics on vessels headed for the United States, seeking to highlight the government’s efforts to take down sophisticated cartel drug networks. Bondi traveled to Florida to tout the seizure of cocaine and marijuana TALLAHASSEE, Fla. — Lawmakers in both chambers of Florida’s Republican-dominated Capitol advanced their respective state budget plans on Wednesday, but the proposals remain billions of dollars apart — and differ from Gov. Ron DeSantis ‘ spending plan for the upcoming year. Wednesday’s floor votes on the budget proposals have kicked off formal negotiations between HARRISBURG, Pa. — A magistrate judge in Pennsylvania accused of shooting and wounding her ex-boyfriend in the head as he slept was convicted Wednesday of attempted homicide and aggravated assault charges. Sonya McKnight was taken away in handcuffs after the trial judge rejected a defense request that she be released. She faces up to BISMARCK, N.D. — Trucks and workers started cleaning up the Keystone oil pipeline spill in rural North Dakota, though its cause and the project timing is unclear. The pipeline ruptured Tuesday morning in southeastern North Dakota and was shut down within two minutes by an employee who heard a mechanical bang. An aerial photo The Museum of Pop Culture , located in Seattle, steps into the realm of folklore and fantasy with its upcoming exhibition, “Asian Comics: Evolution of an Art Form.” In collaboration with the renowned Barbican Centre in London, the limited-time exhibition journeys through the rich, multifaceted world of Asian visual storytelling, paying homage to its historical Deciding when it's time for senior living can be challenging. However, a senior living community can be a positive step toward ensuring safety, health and happiness. Fighting hunger together: Safeway’s, Albertsons’ Nourishing Neighbors program tackles food insecurity‘Preventing the preventable:’ Most effective ways to protect your home from water damage Water damage stands as one of the most common and costly claims that homeowners face, accounting for nearly a quarter of all homeowners insurance claims.The Mountains to Sound Greenway Trust is hosting a tree-planting fundraiser, helping create a sustainable future for local communities, wildlife and the planet.

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