The factory responsible for filling the self-injection pens of the booming weight-loss drug Wegovy, Catalent, has been found to repeatedly breach US sterile-safety rules in recent years, according to a Reuters review of regulatory documents. Inspectors from the US Food and Drug Administration (FDA) visited the Catalent plant in Brussels in October 2021 and August 2022 to assess its compliance with manufacturing regulations, and their detailed reports reveal serious violations.
The FDA inspectors found that air-filtration systems crucial for maintaining sterile conditions at the facility had failed repeatedly between 2017 and 2021, compromising sterility in the area where drug products were manufactured. The lapses at the plant were considered the most serious form of violations, and as a consequence, the facility was shut down twice between the two inspections.
While there is no evidence to suggest that Catalent’s compliance failures resulted in harm to users of Wegovy, the FDA’s findings raised concerns about the safety of all manufacturing activities at the factory, including the production of Wegovy. The drug has gained immense popularity since its approval in the US in June 2021, with millions of people using it to shed pounds. Novo Nordisk, the maker of Wegovy, has enjoyed significant sales and a doubling in market value due to its success.
Wegovy shipments were delayed throughout 2022 as Catalent worked to address the problems raised during the FDA inspections. The FDA issued a final decision in November 2022, allowing the factory to remain open while addressing the compliance issues, as the agency did not deem them a threat to public safety.
Both Novo Nordisk and Catalent have been tight-lipped about the specific issues raised during the inspections. While Novo Nordisk had communicated any manufacturing delays promptly in public announcements, the company did not elaborate on the problems. Catalent maintains that it has a track record of providing high-quality production and addresses compliance issues promptly.
The FDA reports pointed out that Catalent staff did not perform required safety checks, including failing to regularly verify that equipment was not contaminated with microbes. The factory also lacked adequate written procedures for performing tests to prevent microbial contamination during manufacturing, raising further concerns about the sterility of the products.
While microbial contamination in drugs injected into the body can have severe consequences, the FDA inspectors did not report any signs of such contamination at the Brussels factory. However, pharmaceutical manufacturing experts stress that sterility failures during drug filling could be dangerous.
The situation has also drawn investor concerns about Novo Nordisk’s choice of Catalent as its manufacturing partner. Some investors expressed worries about Catalent’s history of compliance issues with the FDA during a meeting with Novo executives. Novo Nordisk has been closely overseeing Catalent’s filling operations for Wegovy in Brussels.
The FDA, while vigilant in addressing potential issues in the global supply chain to maintain consumer confidence in medicine safety, categorized the breaches found at the Catalent facility as “Voluntary Action Indicated,” a less serious designation that allows the manufacturer time to implement corrective measures.
Despite the challenges, Novo Nordisk remains confident in meeting the demand for Wegovy. The supply constraints for the drug are expected to ease by September 2023, as per the FDA website. However, the ongoing regulatory scrutiny and compliance concerns are closely monitored to ensure the safety and reliability of the medication.