Drugs

Biotech Leaders Support Access to Mifepristone

More than 50 biotechnology industry executives and investors have sent a letter to FDA commissioner Marty Makary, urging the agency to reject efforts to restrict access to the abortion medication mifepristone. The letter supports a recent citizen petition by three major medical organizations — the American College of Obstetricians and Gynecologists, the Society for Family Planning, and the Society for Maternal-Fetal Medicine — that calls on the agency to maintain current access to mifepristone.

The biotech leaders emphasized the importance of regulatory stability and scientific integrity, citing FDA’s decades-long track record of safeguarding public health through rigorous, data-driven evaluation. They noted that FDA’s past decisions regarding mifepristone — including initial approval and updated conditions of use in 2016 and 2023 — were based on “numerous high-quality, peer-reviewed studies” involving tens of thousands of patients… Mifepristone has been safely used for decades by millions of women,” the letter reads, adding that risks associated with the drug are comparable to common medications like antibiotics and over-the-counter NSAIDs, as affirmed by the National Academies of Sciences, Engineering, and Medicine.

Additionally, the letter criticized a recent report from the conservative Ethics and Public Policy Center (EPPC) that argued for tighter restrictions on the drug. It describes the EPPC publication as “methodologically flawed,” “self-published,” and lacking peer review — noting that it conflates routine emergency room visits with serious adverse events, ignores FDA definitions, and fails to meet basic standards for scientific transparency.

“FDA has never relied on publications with such unreliable methodologies,” the signatories contended. “Doing so would pave the way for any political or interest group to undermine well-grounded FDA decisions with baseless claims.” They warned that embracing flawed data would destabilize the drug approval process, deter investment in medical innovation, and ultimately harm patients. “Our industries’ investment in the lengthy process of scientific discovery relies on this regulatory predictability,” they wrote.

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