Drugs

3 GOP Senators Push FDA on Chinese Cancer Drugs

Sens. Rick Scott (R-SC), J.D. Vance (R-OH) and Mike Braun (R-IN) are asking FDA for information on why the agency is allowing unapproved cancer drugs from China into the U.S. “rather than addressing the needs of older adults who are impacted by drug shortages.” In a statement (includes the text of the 6/22 letter), the senators say they were “shocked to see FDA announce via a tweet that the administration ‘has taken steps for temporary importation of certain foreign-approved versions of cisplatin products’, meaning from China, without otherwise informing American oncologists.”

In their letter, the senators say the use of a Chinese-approved product without adequate vetting, labeling or communication “may cause frustration among healthcare providers and patients and is especially inappropriate while we are still discovering the truth about China’s role in the Covid-19 pandemic.”

The letter says the three cannot imagine a greater threat to the nation’s drug supply during emergencies than to increase dependence on China. “Instead of responding to drug shortages by accelerating imports of cancer medicines from China,” they write, “FDA should focus on re-shoring production to the U.S.” The senators ask to be updated on how the agency is addressing the needs of older adults who are affected by drug shortages today and how to ensure they will have better access to critical treatments when emergencies arise.

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