Last April, the Food and Drug Administration alerted an untold number of drug makers that marketing applications containing clinical trial data prepared by Semler Research Center, an Indian contract research organization, would not be accepted due to concerns about the integrity of the data.
Now, the company has filed a lawsuit seeking $50 million in damages and accusing the agency of a lack of due process, exposure to claims from customers totaling about $20 million, and the loss of a potential sale that could have yielded $30 million. In short, Stemler alleges the FDA caused a “stigma (that) led to the complete annihilation” of its business.
The FDA “failed to conduct a proper and reasonable investigation under the circumstances to avoid making baseless and unsupported conclusions regarding Sempler’s studies, including failing to independently verify and review all relevant and available data and information regarding” the studies, according to the lawsuit, which was filed last week in federal court in California.
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