Drugs

Senate Bill to Restore FDA Orphan Drug Interpretation

Senators Tammy Baldwin (D-WI) and Bill Cassidy (R-LA) have introduced bipartisan legislation entitled the Retaining Access and Restoring Exclusivity (RARE) Act, which addresses a 2021 court decision that adversely impacts how FDA handles orphan drug exclusivity (see earlier story). A House Energy and Commerce Committee bill (see story) on reauthorizing the user fee programs contains similar legislative language to restore FDA’s long-standing policy on orphan exclusivity decisions.

The RARE Act would codify the agency’s longstanding interpretation of the Orphan Drug Act of 1983 to “ensure that the scope of the orphan drug exclusivity is clarified to apply only to the same approved use or indication within such rare disease or condition instead of the same disease or condition,” the lawmakers say in a release. “This would give FDA the necessary authority to approve the same drug from different manufacturers if they aim to serve different patient populations and combat manufacturers’ efforts to take advantage of the Court’s ruling in Catalyst.”

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