Drugs

White House Intervened in Hydroxy Distribution in April: WaPo

In April, the White House reportedly ordered the National Strategic Stockpile to distribute 23 million hydroxychloroquine tablets from its inventory to a dozen states for treating Covid-19 patients. The drug shipments were sent to several commercial distributors with orders to send them directly to hospitals and retail pharmacies in hard hit areas, according to a 10/31 Washington Post report. Internal documents the Post reviewed also “demonstrate the steps the administration took to bypass the FDA’s March 28 authorization for emergency use of the tablets, which limited their use to hospitals and clinical drug trials,” the report says. According to FDA’s policies at the time, state officials were supposed to request stockpile supplies before they were delivered, but the report says that that procedure was not followed in many cases.

This all occurred during the frantic early days of the pandemic when President Trump and his allies were touting hydroxychloroquine as almost a cure and preventative measure in the fight against Covid-19 (see earlier story). FDA withdrew its emergency use authorization for the drug in June, after it found hundreds of adverse events linked to the drug’s use in Covid-19 patients, including dozens of deaths. Health officials eventually told holders of the pills that they could destroy them, according to the Post.

Much of the White House’s influence in directing the hydroxychloroquine distribution was attributed to president Trump’s trade adviser Peter Navarro, according to interviews by whistleblower and former Biomedical Advanced Research and Development Authority director Rick Bright. HHS officials and a spokesman for FDA commissioner Stephen Hahn told the Post that the efforts to distribute the stockpiled drug were not intended to circumvent the emergency use order, but rather to supply the market for its approved use in lupus patients, who were facing supply shortages.

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