FDA Policy/General

Delayed User Fee Reauthorization Will Hurt Recruitment: Woodcock

Principal deputy commissioner Janet Woodcock says that the Congressional stalemate over advancing the user fee reauthorization package will likely damage ongoing recruitment efforts to bring onboard over 600 new staff for the next five-year user fee period. Asked about this during an Alliance for a Stronger FDA 8/4 Webcast, Woodcock said she feared it will hurt certain large areas like cell and gene therapies because staff they were intending to hire will decide to take other offers if the programs are in limbo.

If the user fee programs are not reauthorized in September, carryover fee balances from the drug user fee program could fund staff for a short period, but it will hurt attrition rates too. She reminded the Alliance of when the reauthorization was delayed in 1997, and it took the agency 18 months to get back to previous staffing levels. “We lost so many people,” she said, adding that due to the very competitive environment right now for hiring people, she is concerned that innovative and cutting-edge programs could be impacted from the lack of staff.

Woodcock seemed optimistic that Congress’ intent is to reauthorize the programs. “That’s not what this has been about,” she said. “It’s been about ‘let’s delay it and just sort of run out the clock,’ but that's not going to work for us.”

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