FDA Policy/General

House Panel Denounces Trump Block on Hahn Testimony

House Energy and Commerce Committee leadership has denounced the White House after it blocked FDA commissioner Stephen Hahn from testifying before the committee this month about potential political interference into Covid-19 response efforts. “The American people deserve to hear Commissioner Hahn’s response to those concerns during a public hearing and what actions he is taking to ensure that the agency’s Covid-19 decisions remain science-based,” the leadership said. “The White House’s muzzling of the FDA’s top scientist further injures public trust and confidence in FDA.”

The committee is probing recent events, including misleading claims about the efficacy of convalescent plasma, because it says they raise serious concerns that the Trump Administration is increasing political pressure on the agency and interfering with its regulatory independence. “An effective long-term response to COVID-19 is dependent on the availability of treatments and vaccines approved by the agency following its long-held standard of safety and efficacy,” the committee says. “Politics should not play any role in these decisions.”

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