Drugs

Danco Seeks High Court Abortion Drug Review

Danco Laboratories, which distributes the abortifacent drug Mifeprex (mifepristone), petitioned 9/8 the U.S. Supreme Court asking it to review last month’s decision (see earlier story) by the Fifth Circuit Court of Appeals that would restrict how the drug is used by, and distributed to, patients.

The company’s expected petition for a writ of certiorari says the case “presents a serious question: whether courts can disregard constitutional and statutory limits on judicial review of executive action in order to overrule an agency decision they dislike.” It also argued that the Fifth Circuit’s merits ruling was “flawed, and equally in conflict with this court’s decisions. Judicial review under the APA [Administrative Procedures Act] asks whether an agency acted ‘within a zone of reasonableness,’ (and) does not permit a court to ‘substitute its own policy judgment for that of the agency.’”

Additionally, it said the high court review should be granted because this is a “case of indisputable importance. For the women and teenage girls, health care providers, and states that depend on FDA’s actions to ensure safe and effective reproductive health care is available, this case matters tremendously. And for the pharmaceutical and biotechnology industry, permitting judicial second-guessing of FDA’s scientific evaluations of data will have a wildly destabilizing effect.”

Meanwhile, the Supreme Court’s next term starts in October. The Justice Department is also expected to request that the court review the case.

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