The Case Of The Suspect Spreadsheet: Semler Sues US FDA Over Data Integrity Concerns
India-based CRO alleges FDA 'annihilated' its business with announcement that sponsors must re-do bioequivalence and bioavailability studies; Semler asserts invalid or falsified study data were never submitted to the agency and FDA's conclusions rest upon a 'suspect spreadsheet' created by a 'rogue employee.'
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Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.
Requiring re-do of Semler bioequivalence studies did not violate the CRO's due process rights, court finds; government has sovereign immunity from 'interference with economic advantage' claims.
Contract research organization’s claims that agency improperly relied on a ‘suspect spreadsheet’ in taking actions that damaged its business are barred by sovereign immunity and exceptions to the Federal Tort Claims Act, FDA says; a federal judge in California will hear arguments on motions to dismiss Jan. 15.