FDA Policy/General

Bill Would Take Food From FDA Responsibilities

Legislation proposed by Rep. Rosa DeLauro (D-CT), chair of the House Appropriations Committee, and Sen. Dick Durbin (D-IL) would remove food safety from FDA’s list of responsibilities by creating a separate Food Safety Administration. In a statement (includes links to the bill text and a fact sheet), DeLauro says “food safety is currently a second-class citizen at FDA. Right now, there are no food policy experts in charge of food safety at FDA. That is unacceptable and contributes to a string of product contaminations and subsequent recalls that disrupt the supply chain, contribute to rising prices and, in many cases, result in consumer illness and death.”

Durbin added that “in recent years FDA has been plagued by one failure after another, from a failure to properly recognize the dangers of prescription opioids to a failure to protect children from e-cigarette products, to a failure to properly ensure the safety of our nation’s food supply. The sad reality is that FDA seems unwilling or unable to protect Americans from preventable illness or death.”

The bill would establish a Food Safety Administration under HHS and place in it the existing FDA food programs. The agency would be led by a food safety expert confirmed by the Senate. DeLauro and Durbin say that in addition to bringing focused leadership and more accountability, a unified structure and a full-time senior leader “will strengthen oversight of the food supply and enhance the industry’s ability to operate effectively.”

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