Genus Life Sciences files a lawsuit over misinformation about where Numbrino was to be manufactured.
A lawsuit has been filed by Genus Life Sciences in the District of Maryland Southern Division seeking to overturn Food and Drug Administration (FDA) approval of a Cody Labs drug based on allegations of falsified reports. The filing contends Cody Labs “misled federal regulators when it moved production of a drug from its Cody manufacturing facility to upstate New York” and that “Lannett (responsible for rolling out the drug) lied to federal regulators when it stated it would be developing and manufacturing Numbrino, a new cocaine-based anesthetic, in Cody” but began to do so in Carmel, New York. It also states the FDA “failed to take legally required actions to begin the process to withdraw approval for the drug” after the revelation surfaced.
The issue centers around Lannett’s decision to close its Cody facility after receiving FDA approval of Numbrino, which the lawsuit states may have been indicative of a move to forgo an additional year of necessary testing in Carmel.
“Months before the agency approved its application, Lannett reconfirmed to FDA that it would manufacture Numbrino exclusively in Cody and that the Cody manufacturing facilities were ‘active’ and ‘ready for inspection,’” the lawsuit states. “Just days later, Lannett told investors that it had ‘ceased operations at the Cody plant’ and was ‘already produc(ing)’ Numbrino at a different facility in New York.”
Lannett filed the documentation needed to begin testing at Cody in September 201 but continued to list Cody as the manufacturing location for Numbrino months after the building was permanently closed. The facility was listed ‘active’ in records used by the FDA to approve the drug despite the fact that the closure occurred months before the FDA approved the application.
“Lannett may have withheld the truth from FDA in order to avoid delaying FDA’s processing of Lannett’s application,” the lawsuit alleges. “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 before FDA could approve the application.”
The Genus lawsuit contends the public’s health was put in jeopardy when the FDA allowed the drug to move forward. It states, “Not only will FDA’s refusal to take the legally required action harm Genus, it also will endanger public health and safety by exposing Americans to a potentially unsafe or ineffective drug made in a facility about which Lannett provided materially false information in the CMC section of its application. By doing so, Lannett deprived FDA of the opportunity to review an accurate CMC section and to decide, based on that information, whether to approve Lannett’s application and whether to inspect the facility prior to approval to ensure that it could manufacture Numbrino safely and properly.”
The bottom line, according to the plaintiff, is that current regulations require the agency to revoke approval should it find there to be false statements made. “If an NDA contains an untrue statement about the facility where the drug will be manufactured, the applicant does not amend the NDA to correct that statement, and FDA subsequently approves the application, then FDA must withdraw the approval upon learning of the untrue statement,” the lawsuit reads.