Drugs

Bipartisan Bill to Shore Up Emergency APIs

U.S. Representatives Abigail Spanberger (D-VA) and Don Bacon (R-NE) have reintroduced a bipartisan bill to create an emergency supply of active pharmaceutical ingredients (APIs) used in essential generic medicines and “incentivize domestic manufacturing of these ingredients.” The measure is intended to reduce the U.S.’s reliance on foreign drug producers. “Generic drugs make up approximately 91% of all prescriptions filled in the U.S. — but about 87% of API facilities for generic medicines are located outside the U.S., with China and India controlling a substantial portion of the supply chain,” the lawmakers say in a release.

Their “Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act” would:

Require HHS to establish and make public a list of essential generic medicines that are medically necessary to have available at all times;
Create a national stockpile of APIs for the essential generic medicines to support the U.S.’s emergency preparedness capacity;
Establish a plan to store, track, test, and convert APIs stored in the reserve into finished dosage forms; and
Reduce red tape that could prevent a drug manufacturer from ramping up production in an emergency.

Click here for the full PREPARE bill text.

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