Bioequivalence and Bioavailability Forum

❝ ... It seem every time when there's major screw-up the one to find them are almost always regulatory agencies.

❝ Alkem's Taloja facility gets clean chit by UK health regulator

Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.

[…] Semler filed a lawsuit against the FDA, the United States Department Of Health And Human Services (HHS) and the United States Of America – along with various individuals – for total damages of approximately $50m (€40m).
The firm claims the FDA’s actions were in violation of the Fifth Amendment, interfered with economic advantages and intentionally inflicted financial distress on the company.
They left Semler with a stigma leading to “the complete annihilation of SRC’s business and its exposure to monetary claims from its customers,” the firm said in its complaint logged with the United States District Court Central District of California.
Among the accusations, Semler said the respondents “failed to conduct a proper and reasonable investigation under the circumstances to avoid making baseless and unsupported conclusions regarding SRC’s Clinical and BA/BE studies,” and failed to conduct its investigation “in a reasonable and prudent manner.”
The plaintiff claims the defendants did this with the “intent of eliminating SRC from the marketplace to the benefit of other CROs,” especially those based in the US and those based in India “with whom FDA Inspectors had personal relationship with the owners or employees.”

[…] In their lawsuit, the company specifically identified all the inspectors who visited its facilities in India for the fateful audit, and their supervisors in the FDA offices in Maryland. First, Semler claims that a rogue employee working in concert with former disgruntled employees intentionally placed a defective spreadsheet on its servers and then pointed FDA inspectors to it. Second, Semler claims that the FDA inspectors had a conflict of interest in their “personal relationship” with competing CROs and acted with the intent to “eliminate” Semler from competition. Third, Semler states that the inspectors did not follow due process. While errors were found in a few studies conducted by the company, FDA extrapolated the findings to all studies conducted by Semler, even those that had previously been audited and cleared by FDA, hence the lack of due process. The company does not deny the accuracy of the findings by FDA inspectors. It also does not justify how its data systems could be breached by one rogue employee or why it could not clarify the errors pointed by FDA inspectors. […] It should be noted that Semler had been audited and cleared by FDA multiple times before. So, a case can be made that if FDA inspectors were incompetent previous times.

PLAINTIFF SEMLER RESEARCH CENTER PRIVATE LIMITED’S COMPLAINT FOR DAMAGES