Drugs

GAO Report Looks at Unannounced Foreign Inspections

A just-released Government Accountability Office report has offered recommendations on an FDA planned pilot program to test unannounced foreign inspections. The pilot will look at bringing foreign inspections on equal footing with domestic inspections, which traditionally have been unannounced. The agency is also looking at eliminating the option of a foreign establishment providing translation services and moving to independent translation services.

“As FDA moves forward, the agency could benefit from incorporating leading practices for designing a well-developed and documented pilot program — such as developing a methodology that details the information necessary to evaluate the pilot,” the report finds. “This would help ensure the pilots provide FDA with the information it needs to assess the value of unannounced inspections and independent translation services, and to decide whether these approaches should be applied more broadly to other foreign inspections.”

GAO also noted that FDA continues to struggle to fill staff foreign inspection positions. It says that:

eight of 20 positions were vacant in FDA’s cadre of drug investigators that conduct only foreign inspections, and
five of 15 drug investigator positions were vacant in its foreign offices located in China and India.

Staffing has been a longstanding challenge that GAO has previously identified. “In 2020 and 2021, FDA began to take steps to identify new strategies to recruit and retain this workforce, but the agency has not yet detailed implementation steps and time frames,” the report says. “Fully developing such tailored strategies could help ensure FDA has the workforce needed to meet its global mission.”

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