Devices

Virus Testing is a Failure: Health Officials

A day after FDA commissioner Stephen Hahn was criticized during a House Appropriations subcommittee hearing 3/11 about delays in testing and a lack of transparency (see story) amid the coronavirus outbreak, National Institute of Allergy and Infectious Diseases director Anthony Fauci told the House Oversight and Reform Committee that testing has been a failure. “The system is not really geared to what we need right now,” Fauci said. “The idea of anybody getting it easily the way people in other countries are doing it, we’re not set up for that. Do I think we should be? Yes. But we’re not,” he testified.

The lack of testing has been a contentious issue with contradictory statements being made by Trump Administration officials, including the president. Testifying at the appropriations hearing, Hahn was toeing the Administration’s line about 2.5 million tests having been distributed throughout the U.S. that could assess almost 1 million patients. Hahn declined to answer a question on the actual number of tests that are being run each day. However, Rep. Mark Pocan (D-WI) noted that recent information from former FDA commissioner Scott Gottlieb indicated that test processing limitations have led to only 16,000 tests being run per day, which should reach 20,000 per day by the end of the week.

CDC director Robert Redfield said at the oversight hearing 3/12 that the CDC has a testing capacity between 300 and 350 tests a day. He said a greater capacity is coming online through private labs like LabCorp and Quest, and the public health labs are not equipped to process a high volume, he said. Earlier in the week, Redfield said the government has “under-invested in the public health labs... There’s not enough equipment, there’s not enough people, there’s not enough internal capacity, there’s no search capacity.”

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