Drugs

Senators Introduce Bill to Reduce Animal Testing

A group of bipartisan U.S. senators have introduced the FDA Modernization Act 3.0, a bill to direct the agency to finally implement the FDA Modernization Act 2.0 (FDAMA 2.0), legislation passed by Congress in 2022 to modernize drug testing protocols and improve patient outcomes. The law removed the requirement that investigational new drugs undergo mandatory animal testing before human clinical trials. Instead, it allows drug developers to use advanced, non-animal methods such as cell-based assays, organ chips, computer modeling, and bioprinting, the lawmakers say in a release.

“Despite the passage of nearly two years since FDAMA 2.0 was enacted into law, the FDA has yet to update its regulations to conform with the law, leaving numerous FDA regulations that continue to call for animal testing,” they complain in the release. “The FDA Modernization Act 3.0 seeks to resolve this by mandating the FDA to update its regulations within six months of the bill’s enactment. It also includes a technical correction to the statute by addressing a duplicated section heading.”

The senators say their measure will reduce unnecessary animal testing while advancing scientific innovation. They say about 90-95% of drugs that proceed beyond animal tests eventually fail during human clinical trials, wasting precious time for patients.

The bill was introduced by U.S. senators Cory Booker (D-NJ), Eric Schmitt (R-MO), Rand Paul (R-KY), Angus King (I-ME), Mike Braun (R-IN), Sheldon Whitehouse (D-RI), John Kennedy (R-LA), Ben Ray Luján (D-NM), and Richard Blumenthal (D-CT)

To read the full text of the bill, click here.

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