Enough Is Enough! Citizen Petition Issues a Clarion Call to FDA to Remove Ranbaxy’s Roadblock to Generic Competition on Several Drugs

By Anne K. Walsh & Kurt R. Karst –      

Earlier this week, Hyman, Phelps & McNamara, P.C. submitted a Citizen Petition to FDA on behalf of a client requesting that the Agency determine that Ranbaxy Laboratories, Ltd. (“Ranbaxy”) has forfeited or is not eligible for first-to-file status for any ANDA subject to FDA’s Application Integrity Policy (“AIP”) (e.g., valsartan, esomeprazole magnesium, and valganciclovir hydrochloride), and that FDA immediately approve all tentatively approved ANDAs for these drugs and any other tentatively approved drugs for which final approval is blocked by Ranbaxy’s alleged eligibility for 180-day exclusivity.

As the Citizen Petition describes in detail, Ranbaxy has a long history of data integrity and manufacturing issues that have resulted in countless recalls of Ranbaxy’s products, the imposition of a Consent Decree requiring strict compliance with current good manufacturing practices, import bans from Ranbaxy’s manufacturing facilities in India, the payment of a multi-million dollar civil fine, and a criminal conviction of the company.  FDA itself recognized that the problems at Ranbaxy were so egregious that they warranted invoking FDA’s rarely used AIP to withhold review of data in Ranbaxy’s applications. 

But, as the Citizen Petition describes, FDA has not gone far enough to protect the public health.  Immediate action is needed.

This petition seeks to level the playing field for all generic drug manufacturers who have not submitted fraudulent applications and seek to comply with FDA’s requirements.  More importantly, this petition seeks to lift the roadblock created by FDA that prevents patients and health care providers from accessing generic versions of drugs while FDA chooses to honor Ranbaxy’s first-to-file status.  . . .  FDA can, and must, declare that Ranbaxy is not eligible for 180-day marketing exclusivity in connection with ANDAs that are subject to FDA’s [AIP], and must immediately approve those ANDAs that have met FDA’s standards and are tentatively approved.  

The Citizen Petition goes on to provide numerous bases for FDA to determine that Ranbaxy’s status as a first applicant otherwise making the company eligible for 180-day exclusivity for drug products subject to the AIP should be revoked.  As noted in the petition: 

Ranbaxy has admitted to submission of fraudulent data to FDA.  FDA has recognized that data in Ranbaxy’s ANDAs are so materially flawed that it invoked the AIP against Ranbaxy to assure that FDA could review applications that contained credible and reliable information. . . .  [T]here are numerous bases for FDA to determine that Ranbaxy’s status as a first applicant on any pending ANDA should be revoked.  To not do so is to reward Ranbaxy for its illegal behavior at the cost of denying consumers low cost high quality generic drugs from other manufacturers.  FDA should immediately approve any and all ANDAs that are being blocked by Ranbaxy’s wrongfully obtained eligibility for marketing exclusivity.