FDA Policy/General

FDA Rehiring Freedom of Information Staff

FDA has begun rehiring some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts. The move was expected after HHS secretary Robert F. Kennedy Jr said 4/21 that the many employees would see their positions restored at FDA and other health agencies’ Freedom of Information Act (FOIA) offices. FDA reportedly missed several court-ordered deadlines to produce documents in April, and this may have motivated HHS to reinstate the employees, according to a report by KFF Health News.

“We are restoring all of the FOIA offices, and we’re going to try to make it much easier for people to get the information,” Kennedy said at an HHS press conference on eliminating food dyes. “We’re going to try to post as much as we can,” Kennedy said. “We’re going to start a Web site with all former FOIA requests and the documents that were produced so people don’t have to do it again and again. We’re going to try to get as close as we can to total transparency in this agency.”

In announcing the FOIA reversal, Kennedy recalled personally his struggles in obtaining information from government agencies. “I spent a lot of years litigating under FOIA, and I experienced the frustration of going year after year and being stonewalled by the agencies,” Kennedy added. “A lot of the people who are at HHS right now come from that background. So we all understand how important it is to have clear communication.”

Asked to clarify the offices' structure, an HHS official told FDA Webview that “the FOIA offices throughout the Department were previously siloed, and did not communicate with one another. Under secretary Kennedy’s vision for a more efficient HHS, these offices will be streamlined, and the work will continue.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome