FDA Policy/General

House Committee Hearing on Reducing FDA Inefficiencies

The U.S. House Committee on Oversight and Government Reform is holding a 4/9 hearing on “Restoring Trust in FDA: Rooting Out Illicit Products.” While no FDA official is invited to attend, the committee says other expert witnesses will testify on the “necessary steps to reduce inefficiencies and bureaucracy at the U.S. Food and Drug Administration (FDA). This includes accelerating the approval of effective, innovative products, preventing illicit and counterfeit goods from entering the U.S., and ensuring a safe and healthy food supply.”

Committee chairman James Comer (R-KY) said rolling back the policies of the Biden Administration is a goal for the Trump Administration and his committee. “The Biden FDA stifled innovation with red tape while allowing counterfeit and dangerous products to flood our communities,” he said. “With newly confirmed FDA commissioner Makary, we finally have a leader who will put Americans’ safety first, not special interests and bureaucrats.” The following witnesses have been invited to testify:

Guy Bentley, Director of Consumer Freedom at Reason Foundation
Jonathan Miller, General Counsel at Hemp Roundtable and Partner-in-Charge at Frost, Brown, Todd
Richard Williams, Senior Affiliated Scholar at the Mercatus Center
Shabbir Imber Safdar, Executive Director, The Partnership for Safe Medicines

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