FDA Policy/General

House Democrats Want Answers on HHS Staff Cuts

Democrats on the House Energy and Commerce Committee say HHS secretary Robert F. Kennedy, Jr.’s “silence on the widespread impacts of public health cuts is deafening.” In a 12-page 5/28 letter to Kennedy, the ranking members on the full committee and its Health and Oversight and Investigations subcommittees ask Kennedy to answer 27 detailed questions about the cuts that they say are an indiscriminate 25% staffing cut and the elimination of various critical support programs.

“Despite our numerous attempts to obtain information on employee terminations at the agencies under HHS, you have not provided Congress with a full accounting of the number of resignations, retirements, or layoffs that have been made as part of either the RIF (reduction in force) or the termination of thousands of probationary employees in February,” the three Democrats wrote. “In the absence of more information and given the fact that these terminations and program elimination decisions were carried out far from public view by unidentified officials, it is unclear whether HHS complied with all laws and regulations in implementing the RIF. We also do not believe the department has the unilateral authority to make the proposed changes to the structure of HHS without the approval of Congress. The staff briefing on 4/11 did not provide any information on the authorities that HHS believes allow it to dismantle its agencies so dramatically.”

The letter continues to press Kennedy to testify before the committee on his plans for the layoffs and plans for HHS.

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