Drugs

Name Covid-19-Related Drug Shortages: Public Citizen

In 3/3 letters to FDA and drug industry associations, Public Citizen says it is important that all drug shortages related to the Covid-19 epidemic be publicly identified. FDA announced the first related medication shortage 2/27, Public Citizen says in a letter to FDA commissioner Stephen Hahn, but refused to identify the medication.

“We are writing to strongly urge your agency to immediately disclose on its Web site and in a press statement the specific drug involved in the shortage and to include such disclosures in all future announcements of shortages of drugs (or other medical products) that are linked to the Covid-19 epidemic, which are widely expected,” the consumer advocacy group says. “Full transparency by all government agencies involved in the response to the Covid-19 epidemic is essential for maintaining the public’s trust. Any hint that the government is hiding important information sows distrust.”

Public Citizen says FDA asserted that the name of the drug is considered to be “confidential commercial information” and countered that it should not be considered such protected information because disclosure of the information would not reasonably be expected to cause substantial competitive harm and because publicly traded drug companies already have an obligation to disclose such information to their shareholders. “Important public health interests must take precedence over any purported industry interest in keeping such information secret,” the letter concludes.

A companion letter to Pharmaceutical Research and Manufacturers of America, the Association for Accessible Medicines, and the Biotechnology Innovation Organization says the organizations “must encourage your members to publicly disclose the names of their specific drugs or biological products that are involved in any shortage resulting from the Covid-19 epidemic.”

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