FDA Policy/General

FY 2021 Enforcement Stats Decimated by Covid

Updated fiscal year (FY) 2021 FDA enforcement and compliance data show just how badly Covid-19 has decimated the agency’s Warning Letter issuance and inspections conducted, among other compliance actions. Of course, when the agency stopped both domestic and foreign inspections in 2020, it was expected to have a dramatic effect on enforcement and compliance actions. But the actual impact over the past two years is now coming to light.

While averaging close to 15,000 Warning Letters issued in FY 2017, 2018 and 2019, FDA issued only 5,512 letters in FY 2020 and 2,419 in FY 2021 (see graph).

Domestic inspections had been been averaging about 14,000 per year in the three years before Covid-19, but in 2020 that number fell to 6,573 in FY 2020 and 5,100 in FY 2021. Regarding foreign inspections, these averaged about 3,400 in the past three pre-Covid years. However, during Covid they dropped to 1,307 in FY 2020 and 99 in FY 2021 (see graph).

And product recalls had averaged about 8,000 recalls annually in the three years before Covid. In FY 2020, this number fell to 5,309 recalls, and in FY 2021 it dropped to 5,309 (see graph).

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