RA/QA News Roll: Mid April 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
Just a quick note that in case you’ve missed our recent FDA-specific news posts, we’ve been gathering the recent flurry of agency news in more focused newsrolls. You can view them all here. We’ll try our best not to repeat ourselves in these standard newsrolls, so be sure to check the other posts for a deeper look at what’s happening at the FDA.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
If you haven’t upgraded to a paid subscription yet, you can do so here. Also, make sure to follow us on LinkedIn and catch the latest episodes of our podcast, The Life Science Rundown.
Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
Also, a quick note: we’ve changed the format slightly to include short titles for each item we link to, so these newsrolls are a bit more scannable.
FDA and the New Administration
Grace Graham named FDA’s new Head of Policy — In a long-expected move, the FDA officially named Grace Graham as Deputy Commissioner for Policy, Legislation, and International Affairs. Graham was previously chief health counsel for the House Energy and Commerce Committee and brings extensive experience with FDA-related legislation, including work on user fee reauthorizations.
FDA to replace laid-off staff with contractors — The FDA is finalizing plans to use contractors to assume responsibilities previously handled by more than 50 laid-off federal employees. These workers had managed travel logistics and financial oversight for the agency’s inspectors. Commissioner Marty Makary reportedly endorsed the plan.
FDA recalling laid-off staff in tobacco division — Following enforcement gaps, the FDA has asked dozens of former staff in its Center for Tobacco Products to temporarily return to work. The request came after the agency realized its ability to issue warning letters to retailers selling tobacco to underage buyers had been significantly weakened.
Telework returns for some FDA employees — The Associated Press reports that FDA review staff and supervisors have been allowed to resume telework two days per week. Some received written notices, while others were told verbally, reflecting inconsistency in the agency’s updated stance on remote work.
OPM preparing for ‘mass offboarding’ of remote federal workers — According to Federal News Network, the Office of Personnel Management is preparing to offboard employees not exempt from return-to-office plans and those accepting voluntary separation incentives. Financial relocation support for remote workers has reportedly dried up.
FDA union flags layoff notice errors, lack of transparency — The National Treasury Employees Union said HHS has not provided required information on impacted FDA employees or legally mandated retention registers. Terminated workers have reported multiple errors in their notices.
FDA’s comms team among hardest hit in layoffs — Roll Call reports that communications professionals responsible for public messaging and strategic planning were disproportionately affected in the recent RIF, further limiting the agency’s external communications capacity.
Kessler defends FDA at oversight hearing — Former FDA Commissioner David Kessler, speaking at a House Oversight Committee hearing on drug safety and supply chains, said, “This feels a little surreal,” citing the contradiction between public expectations for a stronger FDA and the recent staff cuts that have “devastated” the agency. Read his full written testimony here.
Califf suggests FDA could be rebuilt stronger — In an interview with MedPage Today, former Commissioner Robert Califf said the FDA could come back “even better,” thanks to preserved institutional memory and the chance to modernize structures as the agency heads into an era defined by AI and biologics.