A few weeks after ordering employees of the Food and Drug Administration at the office, the agency reverses the course, allowing some of its most precious employees to work remotely in the concerns that recent layoffs and resignations could compromise basic functions, such as the approval of new drugs.
An internal email obtained by the Associated Press declares that the FDA leaders “allow exam staff and supervisors to take up telework” at least two days a week. The change of policy was confirmed by three FDA staff who spoke at the AD on condition of anonymity to discuss internal agency issues.
The message was sent Tuesday to some of the hundreds of FDA drug reviews. Staff members said that similar policy had been communicated to examiners that manage vaccines, biotechnological drugs and medical devices, but not necessarily in writing.
This is the last example of the chaotic approach of the Trump administration toRevision of the federal health workforcethatdismissala raceEngage certain employeesand thenAdditional layoffs last weekOut of approximately 3,400 staff members, or more than 15% of the agency’s workforce.
Last week’s cuts included entire offices focused on the FDA policy and regulations, most of the agency’s communication staff and teams supporting food inspectors and investigators. High civil servants supervisetobacconew drugs,vaccinesAnd other products have also been rejected or forced to resign. Staff members have described employees at lower level as “flowing” of the agency.
The former FDA commissioner, Dr. David Kessler, described the cuts as “devastating, random, thoughtless and chaotic” during a house audience on Wednesday.
WhenHealth Secretary Robert F. Kennedy Jr.announced his intention to eliminate 10,000 employees from the federal health workforce, he noted that FDA medical examiners and security inspectors would not be affected. HHS did not immediately respond to a comment request Wednesday evening.
In February, HHS was forced to recall certain probation employees who have been dismissed, including hundreds of medical revisers at the FDA, who are largely funded by industry costs, not federal dollars.
But last week’s cuts combined with resignations and retirement increased a new threat: this FDA funding could fall so low that it short-circuiting a long-standing system in which companies help finance a large part of the agency’s operations.
Almost half of the FDA $ 7 billion budget comes from the costs collected from medicines, devices and tobacco companies. The agency uses money to hire thousands of staff members to quickly and effectively examine new products. For example, around 70% of the FDA’s drug program is funded by user agreements, which must be reautilized by the congress every five years.
But the agreements stipulate that if the federal funding of the FDA falls below the fixed levels, companies are no longer required to pay and, in some cases, can recover their money. Threshold requirements are designed to guarantee that Congress continues to finance the FDA, rather than relying entirely on the private sector.
The FDA and industry groups are supposed to start negotiations later this year to renew several user understanding agreements, including those of drugs and devices.
“I do not think that the agency or the regulated industry can afford that” user costs “will not be reautilized,” said Michael Gaba, a lawyer who advises companies regulated by the FDA.
Whatever the reasoning behind the quarter -telework, the former federal officials say that it is a sign that recently confirmedFDA CommissionerMarty Makary tries to keep and rebuild the agency staff. Makary made his first appearance at the FDA headquarters last Wednesday, one day after mass layoffs. According to the memo obtained by the AP, Makary signed the return to telework for certain employees.
“Dr. Makary must rebuild the teams and restart the engine of lost productivity in weeks of employment insecurity, uncertainty and shortages of team members,” said Steven Grossman, former HHS official. “The journey time doing time is an excellent first step to reach both.”
This story was initially presented on Fortune.com
