Lannett, the company that shut down Cody Labs after at one point employing more than 100 people in town, is under fire in a lawsuit brought against the Food and Drug Administration by another drug maker claiming Lannett deceived the FDA by claiming Cody Labs was in operation after the facility had shut its doors, according to a filing last month in Maryland District Court.
“Lannett Company made just such a material untrue statement in its application to manufacture and market Numbrino, a cocaine-based anesthetic,” the lawsuit reads in part. “Lannett’s application stated that the drug would be manufactured in a facility in Cody, and the application contained data specific to that facility (e.g., data related to the Exhibit Batches that were manufactured in the Cody facility). In reality, Lannett shuttered that facility while its application was pending and moved its manufacturing operations to a different facility in Carmel, N.Y.
“Lannett’s CMC section thus presented FDA with data about the wrong facility – one that was closed and where Lannett had no intention of manufacturing the drug – and failed to provide critical data about the facility where Lannett actually intended to manufacture Numbrino.”
Genus Lifesciences of Pennsylvania filed the lawsuit, which is asking for declaratory and injunctive relief from the FDA.
The company is asking for the FDA to immediately begin the process to withdraw the Lannett drug due to the false statements it alleges.
The outcome of the case would not likely have any impact on the former Cody Labs location still owned by Lannett, which is being leased out to another company.
In June 2019, Robert Jaffe, Lannett spokesperson, issued a statement saying Cody Labs’ 80-some employees would exit the organization in three phases – the end of June, early August and late September.
Cody Labs equipment had been sold by the end of August and the company was in the process of selling its real estate.
Ric Asherman founded the prescription drug production company in 2000. He sold to Lannett in 2007.
In recent years, as plans to build a multi-building, $50 million production campus on Road 2AB progressed, the Philadelphia-based Lannett expanded its Cody workforce to 126 employees and projected adding 35 new positions.
The facility was still listed as “active” and “ready for inspection” in supporting documents used by the FDA in approving Numbrino in January, despite statements to shareholders announcing the planned closure of the Cody facility roughly 18 months before the FDA approved the Numbrino application. The company shuttered the facility approximately five months before FDA announced its approval.
“Lannett may have withheld the truth from FDA in order to avoid delaying FDA’s processing of Lannett’s application,” the lawsuit alleges, adding that the company would have had to submit more data to federal regulators. “Had Lannett been truthful, it would have needed to wait over a year to gather that data and then file a major amendment to its application (which would have started a new 6-month review cycle for the application), resulting in a lengthy delay (approximately 21 months) before FDA could approve the application.”
Casper Star-Tribune via Wyoming News Exchange contributed to this report