Devices

Lawmakers Press FDA on Covid-19 Test Accuracy

Just how accurate are the Covid-19 diagnostic tests? That’s a question two House lawmakers are asking FDA to provide information on in the wake of testing failures earlier this year involving Centers for Disease Control test kits.

A 4/9 letter from U.S. reps. Lloyd Doggett (D-TX) and Rosa DeLauro (D-CT) requests information about tests currently being used. They said that the “accuracy of recently approved tests is of particular concern because the original CDC test kits, which arrived at public health labs in early February, were flawed, indicating coronavirus in samples which did not contain the virus. Despite clear evidence that the test was fatally flawed, the Administration continued to rely on that inaccurate test for three weeks. This troubling and unjustified delay contributed greatly to the spread of the novel coronavirus in February and March, when those who were infected were not accurately identified and quarantined.”

The letter says that FDA’s ongoing authorization of new tests to “fill the serious gap caused by the Administration’s failure to provide adequate testing raises continued questions. Both a 3/11 study in the Journal of the American Medical Association and the United Kingdom Centre on Evidence-Based Medicine have questioned the accuracy of COVID-19 tests.” The lawmakers note that some physicians are still recommending the quarantine of patients with negative test results because they lack confidence in the tests.

The lawmakers are requesting an update on the current status of information provided to FDA about the accuracy of the COVID-19 tests, including:

* A list of laboratories that have submitted accuracy (sensitivity and specificity) information to the agency

* All information FDA has received from non-laboratory sources regarding the specificity and sensitivity of Covid-19 tests, or any concerns regarding the accuracy of the tests.

* A list of actions the agency has taken in response to performance data submitted, as required by any emergency use authorization

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