Drugs

Administration Argues Covid Not Risky for Abortion Pill Patients: ACLU

The American Civil Liberties Union (ACLU) says the Trump administration has told a federal court that Covid-19 is no longer a serious risk and thus FDA is justified in requiring patients seeking mifepristone to go in-person to a clinical setting solely to sign a form and pick up the abortion pill. An ACLU statement says the FDA policy has been blocked since the advocacy group won a July court order. But, it says, HHS has continued to fight the ACLU position.

“There is no genuine dispute that forcing people to travel to a health center continues to impose serious Covid-19 risks,” the statement says. “That is why the CDC still recommends that patients use telemedicine whenever possible and use mail-order or other delivery services to pick up prescription medications. It is because of this ongoing risk that HHS secretary Alex Azar renewed the nationwide Covid-19 public health emergency and continues to allow patients to obtain addictive medicines like fentanyl and OxyContin through telemedicine.”

ACLU says the courts must continue to block the in-person requirement. It says that once president-elect Joe Biden takes office, he should not only direct FDA to agree not to enforce the in-person requirement during the public health emergency, but also instruct the agency to undertake a comprehensive review of the full set of restrictions on mifepristone. “This will ensure that beyond the pandemic, patients’ access to this safe, effective medication is based on the latest science and medical evidence,” the statement says.

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