The consent decree signed between Indian generic drug manufacturer Ranbaxy and the US Department of Justice (DoJ) serves as a warning shot across the bow for companies supplying to the US market that FDA findings of falsified information in applications or CGMP records will have very substantial consequences.
The decree includes provisions requiring Ranbaxy to: ● thoroughly investigate, with independent expert oversight, the integrity of its submissions and manufacturing operations ● identify how the problems occurred and remove the employees responsible ● put in place the systems, procedures and hiring practices needed to prevent recurrence ● forfeit 180-day exclusivity for some pending applications ● withdraw any applications containing untrue statements or misleading omissions, ● pay stringent monetary penalties for any applications found by FDA going forward to contain untrue statements, and ● meet all relevant provisions before FDA will review applications from the implicated Indian facilities.
Ranbaxy will be required to hire a “chief data reliability officer,” “data integrity expert” and “data quality auditor” to evaluate current systems and practices, identify GMP and data integrity issues, report the findings to FDA and Ranbaxy, and make recommendations on actions to correct the deficiencies.
In scope are applications Ranbaxy has submitted from its Indian facilities as far back as 2003 and all GMP deviations brought to the firm’s attention during the same time frame.
In addition, Ranbaxy must establish an “office of data reliability” in the US to conduct pre-submission audits of all applications from all of its facilities, and the firm may not submit new applications until the office is established. FDA will only accept applications that have been “certified” by the “data integrity expert.”
The “consent decree of permanent injunction” was signed by Ranbaxy and FDA in late December, at which time the generic drug manufacturer announced that it had put aside $500 million to cover potential costs of civil and criminal liability. The decree was filed with the federal court in Maryland in late January and is subject to court approval.
“This action against Ranbaxy is groundbreaking in its international reach,” emphasized DoJ Civil Division Assistant Attorney General Tony West in a justice department press release. It is “unprecedented in its scope,” and will require the firm to make “fundamental changes to its plants in both the United States and India,” he said.
The 58-page consent decree contains sections on: ● definitions ● quality assurance and quality control management ● pending applications ● excepted applications ● CGMP injunction provisions ● data integrity provisions for affected applications ● exclusions ● additional requirements for Dewas affected applications ● withdrawal of unaudited affected applications ● additional injunction provision ● post FDA notice CGMP audit provisions ● post FDA notice data audit provisions, and ● general provisions.
[Editor’s note: An in-depth analysis of the FDA compliance concerns related to GMPs and data integrity that surfaced at Ranbaxy in 2008 and 2009 and put the company on the consent decree path is included in IPQ’s May/June 2009 Special Report on trends in FDA and EU enforcement activities (see pp. 12-14). The current story and analysis continues for subscribers here, and includes links to the FDA injunction complaint and the consent decree. Nonsubscribers can purchase the full story for $195 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]
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