Drugs

ACLU Blasts Trump, FDA on Abortion Pill Requirement

The American Civil Liberties Union (ACLU) is criticizing a second Trump administration Supreme Court petition to uphold an FDA requirement that patients seeking an early abortion pill go to a health center to sign a form and obtain the drug, even during the Covid-19 pandemic. The ACLU says the Supreme Court petition follows a ruling from a Maryland federal court upholding an injunction of the FDA requirement. It says that ruling was the third federal court decision to block the policy during the public health emergency.

In a statement, ACLU Reproductive Freedom Project staff attorney Julia Kaye says the “Trump administration seems committed to jeopardizing the lives of as many people as possible on its way out the door. With Covid-19 wreaking devastation across the nation, and particularly in communities of color, the last thing the federal government should be doing is exposing abortion patients, their healthcare providers, and their families and communities to entirely needless viral risk. The Supreme Court should refuse to acquiesce in the administration’s shameless campaign to punish and endanger people who need abortion care during the pandemic.”

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