Drugs

Hahn Says FDA Increasing EUA Transparency

FDA commissioner Stephen Hahn says that the agency is increasing transparency for Covid-19 emergency use authorizations (EUAs) by posting CDER and CBER reviews of the scientific data and information supporting the issuance, revision, or revocation of EUAs for all drug and biological products, including vaccines. Such a move was recommended in an 11/17 Government Accountability Office (GAO) report.

In an online statement, Hahn says the agency has already posted documents for the revocation of an EUA for chloroquine and hydroxychloroquine and issuance of an EUA for convalescent plasma. Links to the posts are included in Hahn’s statement.

The statement also reiterates steps the agency has already taken to demonstrate transparency, including convening the Vaccines and Related Biological Products Advisory Committee for a general discussion on the development, licensure, and authorization of Covid-19 vaccines and a promise to reconvene the committee to consider specific applications.

The report issued by the GAO called on FDA to identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness when issuing EUAs for therapeutics and vaccines. The report says HHS neither agreed nor disagreed with the recommendation, but said it shared the GAO’s goal of transparency and would explore approaches to achieve that goal. Hahn’s announcement appears to be an effort to meet the goal in a way that GAO had recommended.

In its review, GAO said that the evidence to support FDA’s Covid-19 therapeutic authorization decisions has not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. “Given the gravity of the pandemic,” it says, “it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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