FDA Policy/General

House Commerce Committee Moves User Fee Bill to Floor Vote

The House Energy and Commerce Committee 5/18 unanimously voted (55 to 0) to advance the Food and Drug Amendments of 2022, bipartisan legislation that would reauthorize the agency’s user fee programs and modernize certain programs (see earlier story), such as enhancing post-approval studies for accelerated approval drugs, boosting FDA’s inspection authorities, and improving patient diversity in clinical studies, among others. The measure now heads to the House floor for a full vote.

During the committee mark-up, several members supported the Senate’s direction to seek a new regulatory pathway for in vitro clinical tests in draft legislation released 5/17 (see earlier story). The Senate draft contains a provision entitled Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022, which would amend the Food, Drug & Cosmetic Act to define regulations for in vitro clinical tests. It also provides details for the premarket, abbreviated premarket, and supplemental application review and approval process, and it outlines the information required in such submissions.

Representative Larry Bucshon (R-IN) said he was disappointed that the committee did not take up the VALID Act like the Senate appears to be doing. He said it is time to modernize the regulatory framework for diagnostic tests by “establishing a risk-based framework that allows for leading edge development and innovation to thrive, while assuring doctors and patients have the certainty that their test results are analytically and clinically valid. While I remain disappointed this committee didn't address the diagnostic testing reform in the user fee agreement we are considering today, it is my hope that as we continue through the user fee process with the Senate, Energy and Commerce grabs a seat at the table and shows leadership on this critical issue that directly impacts patient safety. The time is now to answer the call and dress address the pitfalls that exist in the current regulatory framework surrounding laboratory developed tests.”

Without committing to support the VALID Act, committee chair Frank Pallone (D-NJ) did acknowledge the importance of the act’s addition in the Senate draft user fee bill. “Whenever the Senate takes action on anything we have to take notice because it is so very difficult for them to take any action.”

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