Dive Brief:
- India-based CRO Semler Research Center Private Limited is suing the Food and Drug Administration for damages, claiming the agency took actions without "due process, with the intent to inflict financial distress, with the intent to intentionally interfere with [the company's] economic advantage, and without reasonable care and diligence."
- The spat is centered around what Semler has dubbed the "Suspect Spreadsheet," a document that the company contends includes data fabricated by a disgruntled employee.
- The damages claim is for $50 million, which Semler says covers loss of a potential sale of the company it pegs at $30 million and claims from former customers of upwards of $20 million.
Dive Insight:
The FDA carried out an inspection of Semler Research Center Private Limited's Bangalore facility in late September and early October 2015. It reported data violations, including a spreadsheet citing substitutions of one patient's plasma samples for another, exclusions of aqueous humor samples from pharmacokinetic analysis, concentration data being switched and study-related documentation not retained.
From the FDA's perspective, the letter that followed up the meeting stated that Semler had failed to demonstrate its analytical measurements used in an in vivo bioavailability or bioequivalence study were sufficiently accurate, and that its practices and processes resulted in invalid study data. It also called the company's responses to the findings inadequate.
While there were no reports of serious safety concerns, the FDA sent out a "Notification to Pharmaceutical Companies" that clinical and bioanalytical studies carried out by Semler Research "are unacceptable" for new drug applications and abbreviated new drug applications because of "data integrity concerns" and would have to be repeated.
Following the FDA letter and a World Health Organization investigation, the European Medicines Agency recommended the suspension of marketing authorization of approved drugs and resubmission of bioequivalence data for drugs in the approval process.
In the current lawsuit, Semler is challenging the FDA's reliance on the "Suspect Spreadsheet," which it believes was created in concert with a group of former employees working for a competing and undisclosed CRO in Bangalore.
"FDA Inspectors, having seemingly found what they were looking for from the start, thereafter immediately asked the head of SRC’s QA department if she knew what the Suspect Spreadsheet was, to which she responded that she did not, had never seen it before, and would have to look into it," Semler said in the lawsuit.
Semler notes that its replies to the FDA in October 2015 and January 2016 indicated its shock, as the FDA had not raised any such issues previously. The replies also included an independent audit revealing no evidence of data manipulation, and reiteration that the spreadsheet in question was not representative and had been "planted" on the server.
In the lawsuit Semler accuses the FDA of summarily disregarding the independent audit and of contacting its customers without allowing the company to respond.
While it accuses the FDA and the Department of Health and Human Services (and incidentally, the U.S. itself), of ill intent, the 34-page complaint for damages doesn't indicate why the agency would intend to inflict financial distress or intentionally interfere with the Indian CRO.
It remains to be seen what the United States District Court, Central District of California, makes of it.