Drugs

Lawmakers’ Bill on American Drug Independence

Rep. Anna G. Eshoo (D-CA) and Rep. Susan W. Brooks (R-IN) have introduced bipartisan legislation entitled Prescription for American Drug Independence Act. The legislation would require the National Academies of Sciences, Engineering, and Medicine to convene a committee of experts to analyze the U.S.’s dependence on foreign manufacturing of lifesaving drugs and “make recommendations to Congress within 90 days to ensure the country has a diverse drug supply chain to help protect Americans from natural or hostile disasters.

“Our nation’s overreliance on the foreign production of critical drugs and their ingredients has led to drug shortages and subpar quality. The U.S. currently is dependent on China for the key ingredients in antibiotics and blood pressure medications,” Eshoo said in release. “Our country is also dependent on foreign manufacturing of our supply of generic drugs, which represents up to 90% of the prescriptions that Americans take. Our fragile supply chain has long been a problem, and with the Covid-19 pandemic, it’s now an emergency. The U.S. must have a national strategy to eliminate foreign dependence for critical drugs and with it, Congress can move quickly to act on the recommendations of the experts.”

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