Drugs

Lilly Attests to Quality Confidence at FDA-inspected Site

Eli Lilly says it has a high degree of confidence in the quality of the active pharmaceutical ingredient (API) made in Branchburg, NJ following two recent FDA inspections that cited GMP deficiencies (see earlier story). A just-posted Form FDA-483 issued after an August reinspection at the company’s Imclone manufacturing facility found that incidents during GMP activities that may have affected product quality were not investigated. On the laboratory side, the FDA-483 said lab controls “do not include the establishment of scientifically sound and appropriate lest procedures designed to assure that drug substances conform to appropriate standards of identity, strength, quality and purity.” During an 11/2019 inspection, FDA found that appropriate controls were also not exercised over computers or related laboratory systems, according to an earlier FDA-483, which said that identifying quality control laboratory data stored on multiple stand-alone equipment computer systems were not secured from modifications or deletions.

In response to the inspection documents, a Lilly statement says the company is “working diligently to address a total of four FDA observations from the inspections and [we] have performed in-depth investigations into each of the FDA’s areas of concern. For each observation, Lilly has either completed its remediation activities or has put enhanced interim controls in place while our improvements are completed. In each case, we have confirmed that there was never an impact on product quality. In addition, we are taking a comprehensive look at data integrity for the Branchburg site that addresses not only the specific findings but a broader review of manufacturing and laboratory systems at the site. The implementation of our plan is ongoing and is supported by an independent consultant to help ensure that our actions are effective and sustainable. Our goal is to ensure that the Branchburg facility meets all of the FDA’s rigorous Good Manufacturing Practices (GMP) and quality standards.”

Additionally, Lilly says its confidence in the API is bolstered by further quality assurance steps and testing when it is turned into a medicine at other sites. “This constant testing throughout the manufacturing process gives Lilly a very high degree of confidence in the quality of products made with API from Lilly Branchburg,” it says.

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