Drugs

FDA Relaxes Promotion Restrictions on Covid EUAs

FDA is relaxing advertising and promotion restrictions placed on six Covid-19 emergency use authorizations (EUA) after determining that “there may be benefit in clarifying the condition” for “EUA sponsors that wish to include in promotional materials information about the safety and efficacy data that supported the EUA’s issuance.” Previously, these EUAs restricted the sponsors from including in advertising or promotional materials any representation or suggestion that its product was safe or effective for the Covid-related use. The affected EUAs are:

Lilly’s baricitinib
Genentech’s Actemra (tocilizumab)
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab)
Pfizer’s Paxlovid (nirmatrelvir tablets; ritonavir tablets)
Merck’s Lagevrio (molnupiravir)
Lilly’s bebtelovimab

In a 10/27 memo, FDA acknowledges that “dissemination of truthful and non-misleading printed matter, advertising, and promotional materials containing scientific information related to the authorized use of the product, when consistent with the terms and conditions of the respective authorization, can further enhance the public’s awareness of and understanding on the authorized Covid-19 therapeutic.” It also notes that such materials must include any limitations of the clinical trial data as described in the product’s labeling.

Additionally, FDA says that the EUA sponsors are required to submit their advertising/promotional materials for consideration at least 14 calendar days prior to initial dissemination or first use.

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