FDA Policy/General

FDA Has Most of HHS Withdrawn Regulations: Survey

A new Public Citizen report reviewing the 457 rulemakings the Trump administration has listed as withdrawn says that FDA, with 26 withdrawn regulations, had the most of any HHS agency. Five of the 26 were designated as “economically significant,” expected to have an economic impact of at least $100 million. The report says that FDA withdrew a rulemaking that would have required prescription drug labeling information intended for patients to be presented “in a clear and concise” way so patients can “safely and effectively” take their drugs. It also withdrew at least seven tobacco or smokeless tobacco-related rulemakings.

Public Citizen says in a news release that the withdrawn measures “would have protected coal miners, prevented factory explosions, and provided equal rights for same-sex couples.” The release contains links to the report and to a dataset of the withdrawn rulemakings from the government’s Spring 2017 unified agenda released in July.

The advocacy group says the report shows that 26 of the 457 withdrawn rulemakings had legal requirements to meet due dates set by Congress. The agencies with the highest number of withdrawals were the Department of the Interior and HHS, the report says.

Report author Michael Tanglis says administration officials “have taken a victory lap to celebrate their efforts to halt regulations but have largely avoided discussing the details of the rulemakings they have stopped. If combustible dust causes another factory to blow up or if another coal mine explosion occurs, those celebrations will come back to haunt them.”

The report says that 38% of the withdrawn rulemakings were categorized as significant. On average, the rulemakings first appeared on a unified agenda in 2011. Close to 40% (180 rulemakings) had not appeared on a unified agenda in years, meaning that they were likely dormant rulemakings, Public Citizen says.

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