FDA Policy/General

Trust Needed to Boost FDA Morale: Grossman

FDA Matters president Steven Grossman says strong morale will be built at FDA based on a foundation of trust. After reviewing all that has battered the agency in the first year of President Trump’s second term, Grossman raises the question of whether FDA staff morale is primed to rebound or remain on a downward spiral.

“Having worked with so many FDA employees over the years, I know that they are hardworking,” he writes. “I doubt anyone is slow-quitting. However, people can only rise to the occasion for so long before they become exhausted and less productive. Job satisfaction can evaporate.”

The column credits FDA commissioner Marty Makary with avoiding additional reductions in force (RIFs), although it notes that the agency still is losing staff through the forced departures caused by the earlier RIFs and overall attrition due to other job opportunities and retirements. “This has resulted in a significant loss of expertise,” Grossman adds.

He points out that FDA workers need a reason to stay, and job seekers need a reason to want to work at the agency. “Employees need to trust that they will be listened to and not just told to follow orders,” Grossman concludes. “They need to trust that they are making a meaningful contribution to the agency’s mission and positively impacting the lives of Americans. They also need reassurance that they will not be taken for granted. Well-organized groups are always smarter than individuals. That’s true even if the individual is an extremely bright, highly accomplished FDA commissioner. Bosses should never forget: job satisfaction increases where there is a shared sense of accomplishment.”

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