Drugs

Pull Mifeprex from Market: Senators

Some 20 senators, led by Ted Cruz (R-TX), are asking FDA to classify the “abortion pill” Mifeprex (mifepristone) and its generic as an “imminent hazard to the public health” that “poses a significant threat of danger” and remove it from the U.S. market. In a 9/1 letter to FDA commissioner Stephen Hahn, the senators say recent events they detail prove that “it is now nakedly obvious that the abortion industry and its allies in the media, billionaire philanthropic circles, and special interest groups have wanted an unregulated and demedicalized abortion pill since the moment FDA first approved it in 2000…. We believe this deadly pill should never have been approved, yet the abortion industry was politically rewarded with an accelerated approval process normally reserved for high-risk drugs that address life-threatening illnesses like AIDS. As you are surely aware, pregnancy is not a life-threatening illness, and the abortion pill does not cure or prevent any disease. Nevertheless, this pill that is specifically designed and intended to kill preborn children was raced to the market, with devastating consequences.”

The senators say that while the drug’s risk evaluation and mitigation strategy imposes minimal safety standards to protect women, and a minimal standard of care on prescribers, “the fact is that the abortion pill poses a four-times higher risk of complication than surgical abortion in the first trimester. Moreover, the pill will likely fail for between 5% and 7% of women, who often then seek follow-up surgical abortions…. To protect vulnerable women and children, we strongly urge FDA to remove this deadly drug from the U.S. market and use its authority … declaring it an ‘imminent hazard to public health.’”

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