STAT+: Pharmalittle: We’re reading about the FDA closing generic drug office, its U-turn on remote work, and more
A FDA generic drug office was eliminated — and the implications will be felt not only by drugmakers, but consumers
Rise and shine, another busy day is on the way. We can tell because the official mascots got an early start chasing down cats, squirrels, and other creatures darting about the Pharmalot campus. And then there is the noisy parade of vehicles passing nearby on their way to who knows what? As for us, we are firing up the trusty coffee kettle to brew another cup of stimulation. Our choice today is coconut rum. Please feel free to join us. Meanwhile, the time has come to get cracking. So here is the latest laundry list of interesting items for you to peruse. We hope you have a smashing day and, of course, do keep in touch. Best of luck, everyone. …
Amid the hard-to-follow cutbacks at the U.S. Food and Drug Administration, a little-known but important office was eliminated — and the implications will be felt not only by drugmakers, but consumers, STAT explains. The Division of Policy Development in the Office of Generic Drug Policy, which was created more than a decade ago, was responsible for a host of activities that were central to ensuring generic drugs were approved properly for the American market. Now, though, that goal may be in jeopardy. “There are lot of nooks and crannies in the FDA that no one knows or thinks about, but they have an outsized role in generics,” said Kurt Karst, a director at Hyman, Phelps & McNamara, a regulatory law firm, and co-founder of the FDA Law Blog. “…Assuming these functions aren’t somehow transferred somewhere else, years of experience just went poof — gone. But even if they are transferred, who’s up to speed on how all this works?”
Weeks after ordering FDA 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, the Associated Press reports. An internal email states FDA leadership is “allowing review staff and supervisors to resume telework” at least two days a week. The message was sent Tuesday to some of the 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. This is 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 workforce.
