Drugs

Trump Administration Seeks Mifepristone Case Dismissal

The Trump administration 5/5 asked a federal judge to dismiss a lawsuit filed by Idaho, Kansas, and Missouri that seeks to block access to the abortion pill mifepristone via telehealth. In court filings, attorneys for the Department of Justice (DoJ) maintained the legal strategy established under the Biden administration, but refrained from addressing the broader issue of mifepristone access directly, according to the Associated Press. DoJ argued the states lack standing and filed in the wrong venue.

The lawsuit aims to roll back FDA policies that expanded access to mifepristone, which is part of the most commonly used abortion method in the U.S. The case is being heard by U.S. District Judge Matthew Kacsmaryk, a Trump appointee who previously ruled to suspend mifepristone’s approval — a decision later overturned by the Supreme Court.

DOJ attorneys said the states can refile elsewhere but cannot rely on an earlier lawsuit brought by anti-abortion groups to keep the case in Texas. They also argued the states are challenging actions taken in 2016 — beyond the legal deadline to sue.

Abortion laws vary across the three states, from a near-total ban in Idaho to legal access in Kansas and a newly approved constitutional right in Missouri, according to the Associated Press. Mifepristone has been used in over 60% of abortions nationwide since Roe v. Wade was overturned.

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