FDA Policy/General

Not Enough Done on FDA Hiring, Retention: PhRMA

Commenting on the FDA Interim Hiring and Retention Assessment conducted by Booz Allen Hamilton, Pharmaceutical Research and Manufacturers of America (PhRMA) says the agency needs to take immediate action if it is to make substantial progress on the PDUFA 6 and Biosimilar User Fee Act (BsUFA) 2 goals on FDA hiring and retention. The trade group’s comment letter acknowledges that FDA has made efforts to address issues with its hiring and retention capabilities, including through the initiation of a hiring pilot program and initial steps to streamline processes and shorten the time for bringing in new employees.

“However,” the association says, “the findings from the interim hiring assessment show that FDA must devote significantly more effort to make the progress necessary to meet the hiring, recruitment, and retention commitments under PDUFA 6. FDA has had trouble meeting its quarterly hiring goals since the beginning of the current PDUFA cycle. The backlog of hires, new hiring goals, and the potential increase in attrition can undermine the human drug review program’s performance and the agency’s ability to meet its core public health responsibilities.”

PhRMA said it supports the recommendations in the interim assessment and provided specific comments as illustrative examples of hiring, recruitment, and retention challenges that need redress.

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

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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