Drugs

Pharmacists Can Prescribe Paxlovid: FDA

FDA has revised the emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to authorize state-licensed pharmacists to prescribe the Covid-19 treatment to eligible patients with certain limitations to ensure appropriate patient assessment and prescribing. An agency statement says that allowing pharmacists to prescribe Paxlovid could improve access to the drug for some patients who are at high risk for severe Covid-19.

The statement says that under the limitations outlined in the revised EUA, state-licensed pharmacists should refer patients for clinical evaluation with a doctor, advanced practice registered nurse, or physician assistant if any of four specified conditions apply.

Meanwhile, Endpoints News reports the agency said it would not permit pharmacists to prescribe Merck’s Covid-19 antiviral Lagevrio (molnupiravir). The newsletter says FDA informed it the decision was based on several factors, including the drug’s side effects profile and the need for provider-patient consultation before prescribing Lagevrio.

The decision to allow state-licensed pharmacists to prescribe Paxlovid was criticized by the American Medical Association, which said that Paxlovid is not appropriate for every patient and prescribing it requires a knowledge of the patient’s medical history and follow-up care to determine whether the patient is improving. Association president Jack Resneck said in a statement that such care involves “requirements far beyond a pharmacist’s scope and training.”

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