Drugs

Sen. Rubio Seeks to Ban Certain APIs from China

Senator Marco Rubio (R-FL) is asking for immediate FDA action against two pharmaceutical companies based in China’s Xinjiang region that reportedly supply products to the U.S. despite concerns over forced labor. In a 10/30 letter to FDA commissioner Robert Califf that was sent amid heightened scrutiny over human rights abuses in the Xinjiang Uyghur Autonomous Region (XUAR), Rubio cites recent findings that Xinjiang Nuziline Bio-Pharmaceutical Co. and SEL Biochem Xinjiang Co. are permitted to import active pharmaceutical ingredients (APIs) into the U.S. These companies, he argued, are likely involved in forced labor practices prohibited under U.S. law.

Rubio alleged that FDA’s current stance violates the Uyghur Forced Labor Prevention Act (UFLPA), enacted in 2021 to prevent products made using forced labor from entering American supply chains. The act was passed to address the Chinese Communist Party’s alleged human rights abuses, including genocide, forced sterilization, and forced abortions in the XUAR. Rubio contended that allowing these imports compromises both national security and public health by linking U.S. pharmaceutical supply chains to unethical labor practices.

Rubio called on FDA and the Department of Homeland Security to add the two Chinese companies to the UFLPA entity List, effectively barring them from exporting to the U.S., and urged a full review of all FDA-authorized foreign pharmaceutical suppliers to ensure compliance with the UFLPA. “The U.S. has the responsibility of ensuring pharmaceutical and API products are made ethically,” Rubio said, pressing for prompt action from the agency to prevent further violations.

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