Drugs

Bipartisan Bill on Preventing Drug Shortages

Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) have introduced bipartisan legislation to minimize and prevent future drug shortages. The lawmakers says their Drug Shortage Prevention Act was drafted in response to shortages of children’s Tylenol and Motrin over the past few months. It would require manufacturers to notify FDA if they experience six consecutive weeks of an increase in product demand that would help the agency’s “predictive ability and responsiveness.”

In a release, the representatives noted there are ways for the government to be a resource to manufacturers to avoid drug shortages and “Congress must provide manufacturers with mechanisms to proactively resolve these supply chain issues.” The bill would also:

Direct FDA to properly publish and distribute information on a drug shortage to appropriate organizations including physicians, health providers, and patient organizations
Direct the agency to issue draft and final guidance to manufacturers outlining information necessary to improve demand predictability

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