FDA Policy/General

Separate FDA Spending Bill to Get House Vote

The U.S. House of Representatives is planning to vote this week to fund FDA under an Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill as a standalone measure. “Because of the Trump Shutdown, some of the most important activities funded in the Agriculture bill have ground to a halt,” House leaders say. “The Food and Drug Administration cannot accept any regulatory submissions and cannot support many routine regulatory and compliance activities. This includes some medical product, animal drug, and most food-related activities. The FDA also cannot conduct routine establishment inspections, which could prevent the finding and correction of violations, especially for food safety.”

Despite the House efforts, the Senate continues to block spending measures from receiving a vote. Senate majority leader Mitch McConnell (R-KY) refuses to advance any spending bills in his chamber unless President Trump signals he would sign them into law. Sen. Susan Collins (R-ME) has publicly said she would support holding a Senate vote on bills passed in the House to reopen parts of the government unrelated to negotiations over funding for President Trump’s wall along the southern border.

Meanwhile, FDA commissioner Scott Gottlieb said on his Twitter feed that agency employees continue to work on existing applications where user fees were paid prior to 12/22/2018 (when the shutdown began). Among medical product user fee programs, the one that will run out of funds first is likely the drug user fee program, he said, adding that about one month of funding is left. Gottlieb says the agency this week will issue a more detailed analysis of its carryover user fee balances and an analysis about its burn rates.

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