Devices

Committee Dems Hit Azar on LDT Approvals

The three leading Democrats on the House Energy and Commerce Committee say a new HHS policy to allow marketing of laboratory-developed tests (LDTs) without FDA review “could lead to numerous faulty tests on the market, raising serious concerns about the reliability of tests used to detect Covid-19. In a 10/7 letter to HHS secretary Alex Azar, Reps. Frank Pallone (D-NJ), Anna Eshoo (D-CA), and Diana DeGette (D-CO) say FDA jurisdiction over LDTs is warranted during public health emergencies to help avoid false negative results that can have serious adverse consequences.

“We are disappointed that rather than follow this safer, more constructive approach, political leadership at HHS has chosen a reckless path, removing the requirement for LDTs to receive any review by FDA prior to their use during the worst pandemic of our lifetimes,” the representatives write. “This decision will increase the chances of false negative results, endangering countless lives, and weakening our understanding of Covid019 as we head into fall and winter.”

The letter also complains that the “abrupt and cursory nature” of the HHS announcement of the new procedure “has raised many questions about the reach of the new LDT policy and its ramifications for public health.”

The representatives ask for responses to 10 questions about the decision, FDA’s responses to the policy, and the role played by HHS assistant secretary for public affairs Michael Caputo in drafting and announcing the policy change.

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