Biologics

House Committees Expand Emergent BioSolutions Probe

The House Oversight Committee and Select Subcommittee on the Coronavirus Crisis have written to top executives of AstraZeneca and Johnson & Johnson as part of an expanded investigation into manufacturing problems at the Emergent BioSolutions Bayview facility that resulted in millions of doses of Covid vaccine being destroyed or quarantined. A committee statement (includes links to the letters to the companies) says manufacturing at the Bayview facility has been paused since the issuance of a “scathing” FDA inspection report 4/20. More than 85 million vaccine doses have been destroyed and an additional 60 million are being held back to determine if they are safe.

“Emergent’s mistakes have reduced the number of vaccines available for global vaccination efforts,” said the committee chairs. “We are troubled by the impact Emergent’s manufacturing errors has had on the availability of coronavirus vaccine doses, as well as the potential effect on public perceptions regarding the safety and efficacy of these vaccines. We are also concerned about the circumstances that led AstraZeneca and Johnson & Johnson to sign contracts with Emergent to produce their respective vaccines. We need to understand what went wrong and what corrective steps are needed to ensure these mistakes are mitigated and not repeated.”

In each instance, the companies are asked to provide information and documents relating to their contracts with Emergent; the decision to contract with the firm; inspection, audit, or risk assessment reports with Emergent; steps taken to supervise manufacturing, quality, or compliance at Bayview; information on the vaccines produced there; causes of the suspected contamination; and details of costs and cost analyses resulting from delay of production at the Bayview facility.

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