Biologics

Committee Documents Emergent Manufacturing Failures

A staff report prepared for the House Committee on Oversight and Reform and the House Select Committee on the Coronavirus Crisis details manufacturing issues at the Emergent Biosolutions Bayview vaccine manufacturing facility that the report says wasted hundreds of millions of taxpayer dollars and affected the country’s ability to meet the urgent need for Covid-19 vaccines. “Emergent’s inability to meet or maintain quality standards at its Bayview facility, both before and after the Trump administration awarded a multimillion-dollar contract, raises questions about whether additional contracting controls could have prevented the destruction of nearly 400 million doses of coronavirus vaccine and the loss of taxpayer funds,” the report says.

The report makes these points:

Emergent hid evidence of contamination from FDA inspectors and company officials strategized how to evade questions from HHS;
nearly 400 million doses of coronavirus vaccines have been destroyed as a result of the company’s failure to meet or maintain quality standards;
Emergent executives promoted the company’s manufacturing capabilities despite being warned of severe deficiencies;
FDA, Johnson & Johnson, and AstraZeneca identified multiple deficiencies at Bayview that Emergent failed to remediate despite urgent warnings;
inexperienced staff and high staff turnover contributed to vaccine contamination; and
HHS terminated its contract with Emergent because the company failed to follow federal manufacturing standards.

“Given Emergent’s significant lapse in performance on this contract,” the report concludes, “HHS and other federal agencies that contract with Emergent should ensure they are adequately monitoring all the requirements in its remaining government contracts. In the future, the vetting of any prospective federal contracts with Emergent should include a careful consideration of Emergent’s failure to perform under this contract and the actions by Emergent’s executives to keep the extent of its manufacturing problems from its federal and private partners.”

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