Drugs

GenBioPro Sues to Overturn WV Abortion Pill Law

Mifepristone manufacturer GenBioPro has sued the state of West Virginia in federal court to overturn state law that effectively bans the use of the drug for medical abortions. The company argues that FDA regulation of drugs including mifepristone preempts the state law, CNBC reports.

The report notes that since the Supreme Court overturned federal abortion rights last year, some 12 states, including West Virginia, have implemented near-total abortion bans. FDA approved mifepristone more than 20 years ago as a safe and effective method to terminate an early pregnancy. Over the years the agency has restricted how the pill can be distributed and administered.

CNBC says FDA has eased many of its restrictions to expand access to mifepristone which, when used in combination with misoprostol, accounts for about half of all U.S. abortions.

“Individual state regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a federally approved medication to end a pregnancy, resulting in the kind of economic fracturing the framers intended the [Commerce] Clause [of the Constitution] to preclude,” company attorneys said in their filing. “A state’s power does not extend to functionally banning an article of interstate commerce — the Constitution leaves that to Congress.”

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