Biologics

FDA Should Disclose Confidential Drug, Vaccine Data: Article

A California Law Review article by two Yale Law School professors makes the case that FDA should “reboot” its rules to proactively disclose all safety and efficacy data for drugs and vaccines with minimal redactions, deploying data use agreements to ensure the most sensitive data is handled appropriately. The professors write that “clinical trial data publicity can be achieved without legislative reform, while respecting privacy, protecting any legitimate trade secrets, and maintaining or improving incentives to innovate.”

The article (which was completed in the summer of 2020) says the problem of data secrecy is especially visible in the shadow of the Covid-19 pandemic. While billions of dollars in public money were being invested in the development of dozens of vaccines, the authors write, researchers have complained that they have no access to some of the most basic and important information about the design and outcomes of some of the most promising Covid vaccine trials.

“Access to this information could enable scientists to understand key clinical trial decisions in time to influence them, to evaluate the quality of the evidence as it emerges, and to protect against mistakes and misconduct, such as changes in trial endpoints that produce spurious results,” the professors write. “Researchers could also make novel uses of the data collected, advancing our understanding of Covid-19 at a critical time.”

Regulators in Canada and the European Union have taken steps toward greater data disclosure, the article says, showing that it can be done, “but gaps remain that only FDA can fill.” The authors say they demonstrate “how an administration committed to healthcare reform and corporate accountability could reboot FDA and establish an effective proactive clinical trial data publicity regime.”

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