Drugs

Government Turns to High Court in Mifepristone Appeal

The Justice Department says it will seek “emergency relief” from the U.S. Supreme Court after the Fifth Circuit Court of Appeals ruled late 4/12 that while the abortion drug mifepristone can remain on the market it cannot be mailed and thus limits access for women. “The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal, Attorney General Merrick B. Garland said 4/13. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

In granting a stay in part of the lower court’s 4/7 order that would have revoked FDA’s approval of mifepristone (see earlier story), the appeals court panel said it appears that the statute of limitations bars plaintiffs’ challenges to FDA’s 2000 approval, but actions the agency took in 2016 and thereafter to relax access restrictions (e.g., allowing mail order distribution) for mifepristone can be challenged. Additionally, the appeals court said the government had not shown that plaintiffs are unlikely to succeed on the merits of these “timely challenges.”

Reacting to the appeals ruling, University of California, San Francisco’s Advancing New Standards in Reproductive Health (ANSIRH) director Daniel Grossman had this to say: “Today’s ruling is yet another reminder that the power to evaluate and approve medications on the market should remain with the FDA, not politically motivated judges. In restricting access to mifepristone, the Fifth Circuit ignored decades of evidence showing the safety and effectiveness of this medication provided past seven weeks of pregnancy, via telehealth, and dispensed by mail. Junk science has no place in medicine.”

The court said in its ruling that the appeal is being expedited to the next available oral argument calendar.

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