Drugs

Bipartisan Drug Supply Chain Bill Introduced

Reps. David McKiney (R-WV) and Abigail Spanberger (D-VA) have introduced the Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE Act) to create an emergency supply of ingredients used in the manufacturing of vital generic medicines and to incentivize domestic manufacturing of these ingredients. McKinley says (includes links to bill analysis and text) the bill would require HHS to compile a list of essential generic medicines and build out a domestic supply of all the active pharmaceutical ingredients to produce those medicines, with a preference for manufacturers within the U.S.

He says the bill specifically 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 medicines to further bolster U.S. emergency preparedness capacity;
establish a plan to store, track, test, and convert APIs stored in the reserve into finished dosage form and strengthen U.S. capacity for API production; and
cut red tape that could prevent a manufacturer from ramping up production in an emergency.

Identical legislation is being led in the Senate by Sens. Sherrod Brown (D-OH) and Bill Cassidy (R-LA), McKinley says.

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