Drugs

Schumer Pushes Drug Shortage Legislation

Senate majority leader Chuck Schumer (D-NY) says Congress should approve a four-prong legislative solution to the growing nationwide problem of drug shortages. He also called on FDA to activate a plan to limit shortages.

Speaking at a hospital in upstate New York, Schumer said, “I am not only calling on FDA to act immediately and do everything in its power to mitigate this shortage, but I am also urging Congress to take action and solve this issue for good.”

Schumer says that by the end of 2022, there were shortages of 295 critical drugs, including both hospital-based and pharmacy-based drugs. The core reasons for shortages, he said, include insufficient manufacturing, lack of transparency, and reliance on foreign companies.

The senator’s four-prong plan would draft legislation to:

give more transparency and insight into drug shortages;
ensure there are enough manufacturers producing drugs at enough volume to have reserve and contingency supplies;
improve production safety and quality; and
incentivize domestic manufacturing and onshoring.

While some drug shortages can be mitigated by prescribing a different medication form or a therapeutic alternative, he said, “that process is both challenging and time-consuming and not always the perfect replacement for the drug that is in short supply. Additionally, some drugs that are not available have no other replacement option.”

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