Drugs

Senate Amendment Seeks to Prevent Generic Drug Delays

As the Senate prepares for a floor vote Wednesday (12/7) on the 21^st Century Cures Act, Senate Judiciary Committee members led by ranking member Patrick Leahy (D-VT) have introduced a bipartisan amendment to prevent pharmaceutical companies blocking cheaper generic alternatives from entering the marketplace. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was originally introduced in June by Leahy, chairman Chuck Grassley (R-IA), and senators Amy Klobuchar (D-MN and Mike Lee (R-UT), leaders of the Subcommittee on Antitrust, Competition Policy and Consumer Rights. The amendment encourages name brand drug manufacturers to share product samples with generic companies. It further “ensures patient safety by allowing the FDA to require additional information before approving a request for samples of high risk drugs,” a release says. “The original bill and the modified amendment also help generic drug companies develop safety protocols to bring their products to market. Finally, the amendment allows the FDA to more easily approve separate safety protocols.” Text of amendment can be found 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