Drugs

Legislators Hit FDA's India, China Inspections

Bipartisan leaders of the House Energy and Commerce Committee say they are concerned about the effectiveness of FDA drug inspection efforts in India and China. In a 7/18 letter to FDA commissioner Robert Califf, the lawmakers say the agency’s recent decision to address shortages of critical drugs by allowing the temporary import of otherwise unapproved drugs from India and China “makes having effective foreign inspection programs in these countries critical. Chinese and Indian manufacturers receive the most FDA Warning Letters. These violations have included carcinogens in medicines, destroying or falsifying of data, and non-sterile manufacturing processes.”

The letter says that given that about 32% of generic drugs and 45% of active pharmaceutical ingredients come from the two countries, “we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations.”

To emphasize their concerns, the committee leaders cite a Department of Defense announcement that it will independently test the quality and safety of imported generic drugs, a 2022 Government Accountability Office report that criticized FDA foreign inspections, a 2014-15 FDA pilot program in India that appeared to be successful in exposing widespread misconduct and significant violations of FDA regulations but then was discontinued, reduced inspection levels following the Covid-19 pandemic, and inspection and political issues in China.

The letter asks for FDA responses to 10 questions on foreign inspections generally, five questions on inspections in India, and seven questions on inspections in China.

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