Drugs

Drug Shortage Legislative Fix Introduced

Sen. Gary Peters (R-MI) has introduced bipartisan legislation, the Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act, to increase resiliency and readiness in the drug supply chain, easing drug shortages and preparing for future public health threats. A statement says the bill would require HHS to award contracts to quality generic drug manufacturers that are either based in the U.S. or in a country that is a member of the Organization for Economic Cooperation and Development, thus reducing reliance on China for needed drugs.

The bill would require the contract awardees to keep sufficient reserves of key ingredients and finished drug products and bolster production capacity to help prevent potential shortages before they occur. The bill would also prioritize manufacturers based in the U.S. for federal contracts.

Under the legislation, the Government Accountability Office would study whether domestic manufacturing capacity is underutilized and assess how the federal government could strengthen domestic manufacturing capacity for both critical drug products and their key ingredients.

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