Drugs

Congressional Dems Ask SCOTUS Mifepristone Reversal

Some 263 Democrat members of the House and Senate filed an amicus brief with the Supreme Court asking that lower court rulings restricting access to the abortion drug mifepristone be reversed. In a statement from the Senate Judiciary Committee, the Democrats say that at issue in the case are evidence-based regulatory actions FDA took in 2016 and 2021 that broadened access to the drug, including extending the time frame for mifepristone use during the early stages of pregnancy and removing onerous in-person dispensing requirements for it.

The brief says that the district and appeals court rulings “threaten the congressionally mandated drug approval process, and pose a serious health risk to pregnant individuals by making safe abortion care more difficult to access, when access has already been seriously eroded in the aftermath of the Dobbs v. Jackson Women’s Health Organization decision that overturned Roe v. Wade.

“FDA’s determination that mifepristone is safe and effective is based on a thorough and comprehensive review process prescribed and overseen by the legislative branch,” the letter says. “Since mifepristone’s initial approval in 2000, FDA has repeatedly and consistently affirmed that the medication is safe and effective for its approved conditions of use. FDA’s process and conclusions have been validated by both Congress and the Government Accountability Office, and by the lived experience of over five million patients who have used the drug in the United States.”

The members caution that the consequences of the 5th Circuit Court of Appeals reaffirming part of the district court’s ruling “could extend far beyond mifepristone for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective. Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions…. Moreover, the prospect of courts second-guessing FDA’s drug safety and effectiveness determinations will disrupt industry expectations and could chill pharmaceutical research and development.”

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