Gilbert Weiner, now the executive medical director of AdvancedPharma, was cited in the warning letter for failing to conduct hypersensitivity assessments, which the FDA says “jeopardizes subject safety and welfare, and compromises integrity of the data collected at your site,” as well as for missing records.
But Weiner told us the warning letter in question was resurrected from old study records obtained from records management firm Iron Mountain by the FDA and were put together in a hotel room. He told us that the inspector who issued the first Form 483 to him seemed like she was “trying to practice medicine.”
“At the time I had the meeting, they’d already went through all of the records without me over 14 days and called me in to a hotel room for 2-3 hours for two days,” he said, noting it was a “contrived and sneaky way” to conduct the inspection, which they had “no way to verify…since the site was no longer around.”
According to the FDA, Weiner’s response to the agency following the 483 was inadequate because he “did not provide an explanation for the missing study records,” and because he “did not provide a corrective action plan to prevent the recurrence of similar violations in the future.”
Lawrence Galitz, executive medical director at Phase 1 Solutions, worked with Weiner on the Cetero study cited in the warning letter, and told us: "The missing records were Cetero-Pracs' fault. Dr. Weiner left Cetero at the very end of the study. I also left the company prior to Cetero filing for bankruptcy. The medical records were stored at the time at the Miami-Cetero facility per the pharmaceutical company and the FDA. After we were gone we had absolutely no access or control of the records. When Cetero-Pracs decided to close the Miami facility they did not contact either one of us about the study records."
"The executives of Cetero-Pracs should get the 483 or warning letter since they are the ones who lost the records," he added.
Weiner has since hired a lawyer to deal with the accusations made in the warning letter. He maintains that his goals of protecting patients’ safety and well-being and following the protocols of the trial were both met, and he acknowledged that he’s worried his and his current employer’s reputations are being tarnished by this warning letter.
“All the information [for the study] was captured. The integrity of the study was not sacrificed,” he said.
“I had had a legit FDA audit at the same company [Cetero] on site and the inspector spent five days with me and had no 483,” he added. There was “nothing underhanded or anything of that sort and that’s what the FDA should be zeroing in on.”
The FDA told us that it doesn't comment on open investigations.
Weiner also suggested that Cetero’s checkered past may have contributed to the issuance of the warning letter. In June 2012 the company rebranded after data integrity issues dragged the company’s profits down. In March 2013 the rebranded company shut down, filed for bankruptcy and laid off all of its employees.
Galitz suggested as much as well, noting, "Also I spoke with the FDA prior to Dr. Weiner and they already had an agenda about the study before they even looked at the records. I had been audited by the FDA while still at Cetero multiple times in a short period after the problems the FDA had with Cetero. I got 483s on the audit which would not have been 483s if not Cetero."
Weiner noted that the big pharma company who initially paid for the study for the unnamed drug, which is marketed in Asia and Europe, is now “re-doing parts of the study” for the FDA, Weiner said.