Devices

Withdraw AvertD Approval: Scientists

Some 31 experts in genetics, addiction, psychiatry, public health, and medical device regulation are asking FDA to revoke its 1/2 approval of AutoGenomics’ AvertD, the first test to use DNA to assess whether individuals may have an increased risk of developing opioid use disorder (OUD). In a 4/4 letter, the experts say “Current scientific knowledge about OUD genetics is strong enough for us to state that AvertD does not predict genetic risk of OUD.”

The experts report that the company’s claim that the gene markers underlying AvertD can predict OUD was independently evaluated by geneticists who published their findings in a peer-reviewed journal. “This independent evaluation, using a methodology resembling the one used by AvertD’s sponsor, found that the algorithm used for AvertD fell into known pitfalls of genetic prediction that give the appearance of predicting genetic risk, without being a true measure of genetic risk,” the letter says. “With proper controls for ancestry, genetic predictors from the 15 variants used in AvertD did not predict risk of OUD any better than chance.”

The 31 experts say they were surprised that the agency approved AvertD despite opposition from geneticists, other experts, and its advisory committee. “Ironically,” they write, “FDA has touted its approval of AvertD as a step toward addressing the opioid crisis. We believe AvertD may make the opioid crisis worse by contributing to overprescribing to patients who falsely test negative.”

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

Read more

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