Drugs

Senate Committee Has More Drug Supply Questions

Senate Select Committee on Aging chairman Rick Scott (R-FL) and ranking member Kirsten Gillibrand (D-NY) have contacted CVS, Walgreens, and Walmart with additional questions about their efforts to safeguard the integrity of the U.S. drug supply chain. The letter commends the three companies for their “proactive efforts to enhance supply chain management.”

The senators ask the following questions in an effort to gain a deeper understanding of the companies’ approach to safeguarding the integrity of the drug supply chain and its impact on patient care:

how the companies are implementing country-of-origin labeling and according to which standards;
whether the companies receive notification from FDA or suppliers if a product is exempted from an import ban;
whether the companies could ask their distributors and/or manufacturers for the country-of-origin of the active pharmaceutical ingredients for the generic drugs they dispense;
the extent to which the companies contract directly with suppliers; and
whether the companies work with FDA or industry stakeholders in any capacity on the Quality Management Maturity program or any other quality metrics.

“Transparency in supply chains and product labeling is critical to ensuring a healthy market and to promoting quality products,” the letter concludes.

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