The audit reports were at the center of a lawsuit by Ranbaxy, which charged that the FDA unlawfully rescinded two tentatively approved ANDAs (abbreviated new drug applications) because of manufacturing issues, though US District Judge Beryl Howell recently ruled in favor of the FDA.
Audits
The Parexel audit reports were “a specific topic of discussion” between the FDA and Ranbaxy as Ranbaxy looked to get back to producing quality products, according to the suit.
However, the FDA said that its policy of not requesting company audits “does not apply to third party audits,” according to the suit. Parexel defended itself, saying that “disclosing results of audits to the Agency would be destructive to the company’s audit program and be destructive to [the plaintiffs’] quality improvement goals for fear of disclosure of audits to the FDA.”
The agency dismissed those concerns, noting that “audits are routinely received and reviewed by [the agency], and requested to see any information that could be provided by Parexel.” Despite that claim, Ranbaxy’s counsel eventually provided a summary of the audits to the FDA even though they “were initially prepared under privilege.”
But the consequences of not providing the full reports were severe.
“Despite the FDA’s persistent requests to review the audit reports from Parexel, [Ranbaxy] insisted that these audits were privileged and would not be produced…The failure to submit the audits resulted in the withdrawal of an ANDA for clarithromycin, a drug for which the plaintiffs did not have 180-day exclusivity but would otherwise have been able to market at the beginning of 2008,” according to the court’s ruling.
A Parexel spokeswoman referred Outsourcing-Pharma.com to Ranbaxy for more information on the audit reports. Ranbaxy did not respond to a request for comment.
Audit Scope
As to the scope of the audits from Parexel, the company said it was “doing a retrospective verification of stability samples” and that a review of the accuracy of “all current and future ANDA filings.”
“The promised audit results proved to be a sticking point between the agency and the plaintiffs,” Judge Howell wrote. In response to the FDA’s request, Ranbaxy noted that “it was our and Parexel’s understanding that it is FDA’s policy not to review or copy any reports or records that result from such audits” and, consequently, the plaintiffs believed that turning over the report would “affect the candor with which personnel would approach future audits, and make them a far less valuable tool for senior management and for the company as a whole.”
Ranbaxy offered to work with the agency to provide “other relevant materials” while stopping short of producing the audit reports.
But Parexel did not completely defend the actions of Ranbaxy as some of its consultants were involved in meeting between FDA and Ranbaxy staff from 2006 in which the agency expressed concern “that there appeared to be a lack of global corrective actions” in response to a warning letter.
In response to at least one of those concerns, the Parexel consultants noted that certain “information was not provided” to them “when requested” and Parexel said it believed that certain discrepancies between Ranbaxy’s recollection of certain events and the inspectors’ memories was “due mainly to communication barriers.”