Drugs

Affordable Drug Manufacturing Act Reintroduced

Rep. Jan Schakowsky (D-IL) and Sen. Elizabeth Warren (D-MA) have reintroduced their Affordable Drug Manufacturing Act (H.R. 5501), described as an “ambitious proposal to address the skyrocketing price of prescription drugs.” A statement issued by Schakowsky (includes links to bill text and summary) says the measure would lower prices and increase competition in the generic drug market by establishing an Office of Drug Manufacturing in HHS and charging it with manufacturing select generic drugs and offering them to consumers at a fair price that guarantees affordable patient access.

The law says the new Office of Drug Manufacturing would be authorized to manufacture generic drugs under one of these key conditions

no company is marketing the drug;
only one or two companies market the drug and the price has spiked;
only one or two companies market the drug and it is in shortage; or
only one or two companies market the drug, the price is a barrier to patient access, and the drug is listed by the World Health Organization as an “essential medicine.”

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