Drugs

ACLU Suit Challenges Mifeprex REMS

The American Civil Liberties Union has filed suit in Hawaii federal court challenging the FDA REMS (Risk Evaluation Mitigation Strategy) for the Mifeprex abortion pill. The suit, filed on behalf of a Hawaii doctor and several professional healthcare associations says the REMS restricts where a woman may receive Mifeprex, which it describes as a “safe and effective method of ending an early pregnancy up to 10 weeks.” The REMS says that a patient may not fill a prescription for the drug at a retail pharmacy, “which delays and in some cases blocks entirely a woman’s access to abortion.”

An ACLU statement says the suit argues that FDA’s restrictions on Mifeprex don’t meet the requirement that REMS restrictions may only be imposed when necessary to ensure that a drug’s benefits outweigh its risks. Under the REMS, the ACLU says, a patient must be handed the medication at a clinic, medical office, or hospital from a healthcare provider who has pre-registered with the drug manufacturer and has arranged to order and stock the pill.

“Because of these added administrative hurdles or opposition to abortion within their healthcare facilities,” the advocacy group says, “many clinicians across the country are unable to satisfy these medically unnecessary requirements, leaving some patients with no option but to seek an abortion elsewhere, if they can obtain this care at all. For many patients, arranging and paying for an additional trip to a second healthcare provider who has pre-registered and arranged to stock this medication can be challenging or insurmountable.”

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