Drugs

More Regulation Needed for Generics: Bloomberg

A 6/30 Bloomberg editorial is calling for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutical ingredients coming from abroad. The editorial is critical of recent uncovered serious lapses in quality control at Indian pharmaceutical factories making generic drugs for U.S. consumers. “These findings raise questions about the extent of such failures and whether the Food and Drug Administration is doing enough to assure the safety of imported medicines,” it says.

Bloomberg editors urge stronger oversight by FDA as part of the solution. “The FDA says it follows rigorous drug-safety protocols involving random lab testing, regular on-site audits and screening at ports of entry,” they say. “It also reviews drugmakers’ ‘master files,’ which include detailed information about sourcing and production processes. Yet the agency relies on the willingness of companies to cooperate, and too many have shown they aren’t to be trusted. The pandemic, which essentially halted in-person audits, gave dodgy manufacturers more room to cut corners.”

The editorial notes that Congress recently authorized $10 million on an FDA pilot program for more frequent overseas audits. “Measured against the potential benefits, that’s a trifling sum,” it says. “This effort should be made a higher priority and given the resources it demands. It also supports an FDA-proposed quality metrics program that will publicly grade manufacturer’s quality controls so buyers have more transparency in the products they purchase. “Published quality metrics would help the market to discriminate,” the editorial explains. “Better producers would be rewarded and standards would rise. There’d be fewer lapses to discover, hence fewer interruptions to supply.”

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