Drugs

Pfizer Addressing Hospira Problems to Remediate by Next Year

Pfizer officials say they have submitted a corrective and preventative action plan to FDA on remediating GMP issues at Hospira legacy facilities, and significant progress is expected in 2018. Pfizer acquired Hospira in 2015 and it has struggled to bring troubled facilities into GMP compliance.

Earlier this year, FDA sent Pfizer a Warning Letter after inspecting a Hospira drug manufacturing facility in McPherson, KS, and finding significant GMP violations (see story). These included failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, failing to establish valid in-process specifications, and failing to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

Additionally, FDA’s letter chastised the company for not submitting field alert reports and noted that it found similar GMP violations at other facilities in the company’s network. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” it said.

During a 10/31 earnings call, Pfizer officials said there have been supply challenges primarily related to legacy Hospira products that have had a negative impact on projected 2017 revenues of several hundred million dollars. “When we acquired Hospira, we originally thought it would take one to two years to integrate the manufacturing plants and resolve the majority of the supply chain issues,” they said. “We have a robust action plan in place, and we believe we will make substantial progress in 2018 towards reducing the sterile injectable shortages.”

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