Devices

FDA Needs Legal Authority to Regulate Diagnostics: Pew Charitable Trusts

The Pew Charitable Trusts says Congress should act quickly to approve legislation establishing a “unified, risk-based FDA regulatory system for diagnostics, including laboratory-developed tests (LDTs).” A 1/11 Issue Brief says the need for congressional action was heightened by an 8/2020 HHS announcement that FDA does not have authority to require the pre-market review of LDTs, including tests for Covid-19, unless the agency goes through a lengthy rule-making process.

“The HHS decision ended FDA’s ability to conduct even expedited reviews of LDTs, increasing the chances that an unreliable Covid-19 test could enter the market,” Pew says. “It also casts doubt on FDA’s ability to protect patients if the agency learns of a faulty LDT that is already on the market.”

The brief lists six LDT risks and presents case studies to illustrate some of the risks and highlight ways Pew believes that stronger FDA oversight of the diagnostics market can help mitigate the risks and protect public health.

Pew calls attention to the Verifying Accurate, Leading-Edge In vitro clinical test Development (VALID) Act, bipartisan legislation introduced 3/2020. It says the bill “would make clear that LDTs are subject to FDA’s review requirements for in vitro diagnostics. It also reportedly would provide the agency with the tools necessary to monitor the diagnostic market and protect patients when safety concerns arise with a test.

“Congress should move quickly to consider such proposals and approve legislation that establishes a unified, risk-based FDA regulatory system for diagnostics, including LDTs,” the brief concludes.

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