According to MannKind Corporation, it has completely resolved arbitration initiated by a lawsuit filed by its former Senior Director – GCP – Regulatory Affairs, John Arditi, in 2010. Arditi, who had been responsible for MannKind’s GCP compliance audit program, claimed in the lawsuit that he was terminated in retaliation “for his diligence and insistence on quality standards, when it conflicted with MKC’s desire to withhold information from the FDA” related to clinical trials for Afrezza inhaled insulin, including trials in Russia and Bulgaria.
Arditi has now withdrawn his claims and issued the following statement: “I do not believe there was fraud or scientific misconduct on the part of investigators nor do I believe there is any question regarding the reliability and integrity of the data collected in MannKind’s clinical trials while I was employed. I am proud that I was part of a team that achieved full GCP compliance with respect to the Afrezza new drug application during my employment.”
At the time, MannKind denied both retaliation and withholding information from the FDA, and announced that an independent investigator “concluded that MannKind is, and was, taking prudent measures under Good Clinical Practice regulations to meet the requirements of Good Clinical Practices, and that there was no evidence of any deception or intent on the part of MannKind to deceive the FDA.”
MannKind says that it has also withdrawn its claims against Arditi and that “Neither party paid any monetary consideration to the other party” as part of the settlement. The company’s Chairman and CEO Alfred Mann commented, “Peter Richardson, Patricia Mayer and the entire team set extremely high standards for quality in our earlier clinical program, and then exceeded those standards in a professional and diligent manner. I have been emphasizing the importance of getting our current Phase 3 clinical studies underway in a timely manner, but I do so knowing that we have an unwavering commitment to quality.”
In August 2011, the FDA and MannKind agreed on new clinical trials that will evaluate safety and efficacy of Afrezza as delivered by MannKind’s next generation inhaler, which replaced the original MedTone inhaler used in the original trials.
Read the MannKind press release.
