Drugs

Lilly Internal Investigation Finds No Wrongdoing

An Eli Lilly investigation into whether a company executive altered manufacturing documents required by FDA found no wrongdoing, according to a Reuters report. Law firm Covington & Burling spearheaded the probe of an internal Lilly complaint that alleged a Branchburg, New Jersey factory executive changed technical documents required by regulators to downplay serious quality control problems at the facility that makes the company’s bamlanivimab Covid-19 therapy (see earlier story).

In a memo to Branchburg employees obtained by Reuters, plant head Nellie Clark summarized the investigation’s findings: “In the end and very importantly, allegations that Lilly made false statements to the FDA were not substantiated.”

Last month, Lilly reported that it received a subpoena from the U.S. Department of Justice requesting certain documents about the troubled manufacturing site. Late last year, FDA posted a Form FDA-483 detailing significant quality and laboratory control issues found during an 8/2020 reinspection at the Branchburg facility. The FDA-483 said that there was a quality failure to “thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.” For example, FDA said incidents that occurred during GMP activities that may have had an impact on product quality were not investigated.

The reinspection followed an 11/2019 inspection and according to an FDA-483 appropriate controls were not being exercised over computers or related production systems at the facility. The agency said that electronic files identified as Calibration Study, Qualification Study and Verification Study had been deleted, adding that the “deleted incidents and related audit trail were not reviewed by the quality unit.” Appropriate controls were also not exercised over computers or related laboratory systems, FDA said, specifically identifying quality control laboratory data stored on multiple stand-alone equipment computer systems that were not secured from modification or deletion.

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