Drugs

Generic Mifepristone Maker Sues FDA

GenBioPro, the generic drug maker of abortion drug mifepristone, filed a 4/19 lawsuit against FDA in Maryland federal court to block the agency from taking any actions against the company if a pending court order under review by the U.S. Supreme Court requires the drug to be restricted (see earlier story). The lawsuit comes on the eve of the Supreme Court’s 11:59 PM-expiring stay of a lower court decision that could restrict mifepristone’s distribution if the high court does not take further action.

The company’s lawsuit seeks to “enjoin FDA from depriving GenBioPro of its constitutional and statutory rights to market mifepristone without affording GenBioPro due process of law, and to prevent defendants from upending nearly a quarter-century of public reliance on a safe and effective drug by bringing criminal and civil enforcement actions against GenBioPro, its agents, manufacturers, distributors, partners, and customers.”

GenBioPro’s complaint says FDA has repeatedly refused to assure the company that it will be afforded “adequate procedures before suspending GenBioPro’s ANDA approval. Nothing in the FDCA or in the U.S. Constitution permits FDA to violate federal law in determining how to navigate these court orders or other external events,” it says. “On the contrary, Congress specifically mandated, and the Constitution requires, a procedure the agency must follow before it deprives an ANDA holder of its rights.”

Additionally, the company says it is worried about potential FDA actions after the government told the Supreme Court that generic mifepristone will “become misbranded” and GenBioPro will be “without an effective drug approval” as a result of the court order if it is allowed to go into effect.

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