Drugs

FDA 2020 Covid Drug and Biologic Activities Analyzed

Attorney Joanne Hawana (Mintz) says the most important thing FDA did in authorizing two mRNA Covid-19 vaccines at the end of 2020 was to be as transparent as possible. Writing in an online year-end review of FDA’s Covid drug and biologic activities, Hawana says the publicly available materials for the Pfizer vaccine included an internal review and decision memorandum, “which is more documentation of the agency’s reviewing and thinking on the Section 564 standards for authorization than we have seen for most of the issued emergency use authorizations during the current public health emergency, whether for therapeutic or medical device products.”

Hawana writes that the posting of the internal memorandum underscores the ongoing importance of FDA restoring and maintaining its scientific credibility with the first vaccine authorization.

“Still,” she says, “vaccine hesitancy remains a public health challenge, partly because of the Trump administration’s politicization of FDA during the pandemic and partly for other reasons including longstanding distrust of modern medicine among some subpopulations. Ensuring the successful implementation of a national vaccination program will be one of the first public health priorities of the Biden administration when it assumes leadership of the federal government on 1/20/21.”

The agency’s eight therapeutic product emergency use authorizations approved since the beginning of the pandemic are reviewed along with the now-revoked authorization for hydroxychloroquine and the fully-approved use of remdesivir in patients over age 12 hospitalized with Covid-19.

Hawana says FDA spent considerable time acting against companies trying to capitalize on the pandemic by marketing fraudulent Covid-19 products.

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