FDA Policy/General

GAO Pushes Its FDA Recommendations to Kennedy

In a 5/7 letter to HHS secretary Robert F. Kennedy, Jr., the Government Accountability Office (GAO) highlights open recommendations for FDA that it says warrant his attention. The letter particularly references a recommendation that HHS ensure effective FDA oversight. It says that protecting public health through enhanced oversight of medical products has been on GAO’s High Risk List since 2009.

It notes that FDA began opening overseas offices in 2008 to obtain better information on products coming into the U.S. and perform inspections. “While FDA has taken some steps to assess the effectiveness of its overseas offices, FDA has not yet demonstrated that it can systematically measure whether the offices’ activities contribute to drug safety-related outcomes as we recommended,” it says. “With such information, FDA could better assess how overseas offices’ contributions help ensure imported drugs are safe.”

It also says GAO recommended that FDA develop and implement plans to address the causes of investigator attrition.

In a listing of open priority recommendations, GAO calls attention to a 2024 recommendation that FDA implement strategies to retain its inspection workforce, a 2020 recommendation that the agency strengthen efforts to provide effective oversight of medical products, and a 2017 recommendation that FDA assess the effectiveness and staffing of its foreign offices.

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