Drugs

Senators Question FDA Oversight on Covid-19 Products

Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA) have written FDA asking how the agency is tracking the use, safety, and effectiveness of scores of products on the market under emergency use authorizations (EUAs). Since 2/4, FDA has issued 112 EUAs for Covid-19-related medical products, which places a burden on the agency to track the usage of these newly-authorized products, wrote the lawmakers in a 5/6 letter to commissioner Stephen Hahn.

The senators are concerned that federal law mandates the monitoring and reporting of adverse events in certain products marketed through EUAs. For example, they questioned a 3/28 EUA for hydroxychloroquine issued not long after President Trump contacted Hahn and questioned whether they were moving rapidly enough to make the drugs more widely available. “We are concerned that the EUA may been issued despite known issues relating to safety, efficacy, and quality,” the letter said. “There is limited evidence of hydroxychloroquine’s effectiveness in treating Covid-19, but well-known lethal cardiac side effects.”

The letter also raised the recent EUA for Gilead Sciences’ antiviral drug remdesivir. “Given that demand for remdesivir will likely be extremely high, it is imperative that the FDA track and analyze all available data and information associated with the administration of remdesivir under the EUA, including reported adverse events, to ensure that remdesivir’s benefits outweigh its risks,” it said.

The senators asked FDA to describe the systems and procedures that it has in place for tracking adverse events related to all EUAs granted recently. They also asked the agency to describe the systems and procedures that are in place for tracking postmarket outcomes data on Covid-19-related medical products.

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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