Drugs

Rubio, King Push FDA on Advanced Drug Manufacturing

Sens. Marco Rubio (R-FL) and Angus King (I-ME) are urging FDA to develop clear regulatory guidelines for advanced manufacturing technologies (AMT) for drugs. In a statement (contains the text of their letter to FDA commissioner Robert Califf), the senators say that with “insufficient levels of domestic pharmaceutical manufacturing, America’s public health and national security are dependent on our foreign adversaries. But the industry needs clear guidance when investing in domestic manufacturing.”

Rubio and King say that advanced manufacturing technologies, such as continuous manufacturing sites, provide a promising pathway to lower the cost of domestic drug manufacturing and accelerate the return to the U.S. of key active pharmaceutical ingredient production. “Yet,” they continue, “FDA has not yet invested sufficient resources toward developing clear regulatory guidelines for these innovative manufacturing tools. FDA must quickly finalize and implement the AMT Designation Program, as directed by Congress, to provide companies regulatory clarity as they evaluate whether to invest and seek approval of AMTs for their products.”

The senators ask for answers to these questions:

the strategies FDA has implemented to encourage greater investment by domestic drug manufacturers into AMTs;
how the agency is ensuring that the AMT Designation Program will benefit more domestic manufacturing facilities than foreign-based facilities;
the ratio of domestic to foreign-based applications in the current application pool for AMTs seeking approval through current active pathways;
whether FDA has received any new continuous manufacturing applications for generics, especially for those with domestic shortages;
how FDA is communicating about the AMT Designation Program to eligible entities and the public;
how FDA is ensuring timely approval of continuous manufacturing technologies;
whether FDA has seen continued growth in the number of approved continuous manufacturing products since 2022; and
the implementation status of the AMT Designation Program, including implementation progress since a draft guidance was issued, and whether the program has accepted any designation requests for new technologies.

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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’

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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

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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