Biologics

FDA Loses Again in FOIA Suit on Vaccine Records

A Texas federal court 12/6 ruled against FDA in an ongoing Freedom of Information Act (FOIA) lawsuit by Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The group sued FDA in 2021 and the agency was ordered in 2022 to produce 55,000 pages each month from the supporting documents behind the BLA approval.

After 1.2 million pages received, plaintiffs recently asked the court to compel the agency to produce documents that Pfizer relied on to obtain an emergency use authorization (EUA) prior to its BLA approval. However, FDA argued that the EUA file does not fall within the FOIA request because the BLA and EUA are separate applications that are subject to different standards. The agency further contended that an FOIA request for one does not necessitate production of the other.

“The COVID-19 pandemic is long passed and so has any legitimate reason for concealing from the American people the information relied upon by the government in approving the Pfizer vaccine,” the court ruling said. It further relied on earlier FDA statements that the EUA was not “mere[ly] reference[d]” in the BLA but that the BLA incorporated and relied heavily on the EUA. Additionally, it found that the EUA was “submitted with or incorporated by reference in” Pfizer’s BLA, adding that “Either way, the EUA must be produced.”

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