Drugs

High Court Issues 5-day Stay in Abortion Drug Case

The U.S. Supreme Court has ordered an administrative stay until 4/20 of a lower court’s 4/7 order (see earlier story) that would restrict the distribution of the abortion drug mifepristone. The stay gives the high court additional time to review a 4/14-filed appeal by the Department of Justice that is seeking a longer stay while the lower court’s order is appealed in the U.S. Court of Appeals for the Fifth Circuit.

The DoJ appeal “concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” the government says in the appeal. Approved in 2000, FDA has maintained its scientific judgment “across five presidential administrations, and it has modified the original conditions of mifepristone’s approval as decades of experience have conclusively demonstrated the drug’s safety,” the government contends. “Public health authorities around the world have likewise approved mifepristone, and the World Health Organization has included it on a list of ‘essential medicines.’”

The appeal says the district court’s order would nullify FDA’s approval and effectively prohibit mifepristone from being introduced into interstate commerce, “upending the status quo based on the court’s deeply misguided assessment of mifepristone’s safety… The Fifth Circuit stayed the district court’s suspension of FDA’s original approval of mifepristone. But it refused to stay the suspension of subsequent updates to the conditions on the drug’s use, which have governed the drug’s distribution for seven years and provided a safe and effective option for women who would otherwise have to undergo a surgical abortion.”

It further said that if allowed to take effect, the lower courts’ orders would “upend the regulatory regime for mifepristone, with sweeping consequences for the pharmaceutical industry, women who need access to the drug, and FDA’s ability to implement its statutory authority.”

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