Drugs

Disqualify 2 Minnesota Researchers: Public Citizen

A Public Citizen petition calls on FDA to disqualify two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.” The advocacy group says the doctors conducted a series of clinical trials that tested the general anesthetic ketamine and powerful sedatives on agitated patients without their consent.

The petition also calls on FDA to disqualify the medical center institutional review board (IRB) for violating federal human subject protection regulations by approving the trials without ensuring that informed consent requirements for such experiments were implemented.

Public Citizen says the violations involved four separate clinical trials conducted from 2014 to 2018.

FDA inspections in 2018 and 2019 resulted in May Warning Letters to the two doctors stating they had conducted their clinical trials without submitting an IND. The agency also found that the doctors and the IRB did not comply with regulations requiring informed consent for clinical trials. And the IRB was cited for failing to ensure that additional safeguards were implemented in the four trials to protect subjects considered to be vulnerable to coercion or undue influence.

Public Citizen says that under the disqualifications it is seeking, the doctors would be prohibited from conducting clinical trials testing experimental drugs or medical devices for a specified period and the IRB would be ineligible to review such FDA-regulated trials.

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