Drugs

FDA Covid Drug Limits Criticized

Cato Institute senior fellow Jeffrey Singer, a general surgeon, and American Council on Science and Health director of chemical and pharmaceutical science Josh Bloom say two FDA requirements that are part of the emergency use authorizations for two Covid-19 antiviral drugs “all but guarantee that most people who need them will not be able to get them in time.” Writing in a New York Post op-ed, Singer and Bloom say time is important since the drugs, Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) and Merck’s molnupiravir, are only effective when used within five days of initial symptoms.

The article says the agency lists numerous health criteria as prerequisites for a prescription for the treatments, “repeating the same mistake the agency made when it first approved the Pfizer and Moderna vaccines. While health considerations may seem reasonable, perhaps even wise, the logistics of applying existing health risks as a condition for dispensing the drug make the process cumbersome and unworkable.”

Singer and Bloom say the list of conditions is “arbitrary and vague” and assumes that a patient is able to get to see a doctor in time.

They express concern that doctors in over-burdened clinics and urgent care centers will not be able to spend the time necessary with likely new patients to be able to determine if they are high risk, meaning that urgent care centers probably will not be able to prescribe the drugs.

Their second concern is that FDA requires a positive test and the current waiting time for PCR test results from a commercial laboratory is four days. In addition, they say, home tests are in short supply and they doubt that a doctor would prescribe the medications based on a patient’s reported home test result.

“A better approach would be for FDA to remove the testing requirement, stop micromanaging nuanced clinical decision-making, and let doctors use their knowledge and judgment in deciding to whom and when to recommend the drugs,” Singer and Bloom conclude.

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