A groundbreaking judgment against a major generic drug manufacturer
Following a lengthy investigation that uncovered numerous data and FDA application problems, on behalf of the Food and Drug Administration (FDA), the United States Department of Justice (DOJ) filed a consent decree against the Indian generic drug company Ranbaxy Laboratories, Ltd., in January 2012. In a separate announcement, Ranbaxy’s parent company reported that it had also set aside $500 million to cover investigation costs and pay fines and penalty fees levied by the government. It was not the first time an action had been taken against the generic drug manufacturer.
Actions against Ranbaxy (click here for more)
Actions against Ranbaxy
- In 2002, Ranbaxy was issued their first FDA Warning Letter citing new drug approval issues.
- In 2004 the World Health Organization (WHO) sanctioned Ranbaxy and forced it to remove its generic AIDS drugs from the WHO approval list because of faulty application test data.
- In 2006 and 2008, the FDA issued Warning Letters (click here, here, and here) concerning serious deficiencies at two Ranbaxy facilities
- In 2008, the FDA issued an Import Alert and banned new lots of more than 30 adulterated Ranbaxy generic drugs from U.S.pharmacies and the President’s Emergency Plan for AIDS Relief international AIDS program.
- In 2009, Ranbaxy was put under FDA’s Application Integrity Policy (AIP).
- In 2012, Australian authorities revealed that Ranbaxy had bribed pharmacists and offered them $15,000 of free stock for dispensing Ranbaxy’s atorvastatin, the generic version of Lipitor, instead of other generic brands.
- In June of 2012, five months after signing the consent decree, Ranbaxy’s sales, marketing, and manufacturing were suspended for four days by the state of Maharashtra in India. (link)
- In 2012, Ranbaxy withdrew 27 generic drug applications from FDA.
- On March 25, 2015, the sale of Ranbaxy to Sun Pharma was completed
Uncovering Ranbaxy problems
Prevent Medical Error (PME) wants to publicly acknowledge and thank everyone who has helped investigate Ranbaxy activities – from the WHO officials who first identified application problems in 2004 to United States authorities to the Ranbaxy insider who reportedly blew the whistle on the company.
PME, a 501 (c) (3) nonprofit organization, has also worked relentlessly not only to get at the truth about the harm adulterated Ranbaxy drugs have caused patients, but also to get these drugs off the market and out of PEPFAR. Over the last ten years PME has devoted more than $250,000 to identifying and assisting victims of adulterated Ranbaxy generic drugs, and to helping authorities and victims obtain justice. We are grateful to all those who assisted in our efforts. In particular, PME would like to recognize the patients, physicians, and pharmacists who came forward, and the state and federal authorities and officials who listened and took action.
Why PME took on Ranbaxy
When PME’s founder was working as a volunteer patient advocate, she began noticing a possible link between medical problems patients were experiencing and certain Ranbaxy generic drugs they were taking. Ironically, the following year she was prescribed a generic antibiotic manufactured by Ranbaxy and, as a result, she was permanently disabled.
In spite of her poor health, she worked tenaciously to try to get and keep adulterated Ranbaxy drugs off the shelves, identify potential problems, fight for patients who have been harmed, and educate people about drug safety issues.
She and PME have uncovered, tracked, and helped corroborate dozens of incidents of suspected patient harm caused by adulterated Ranbaxy generic drugs. Their findings have been reported to the appropriate authorities. In addition, PME has collaborated with other organizations, authorities, and officials to help prevent patients from taking adulterated drugs.
Justice for patients who took adulterated Ranbaxy drugs
At the time of their Import Alert and ban, the FDA indicated that the adulterated drugs that were already in the country were safe for patients to continue to take (link), and despite calls, state and federal authorities were not able to seize them. FDA’s current official position is that even when the FDA issues a Warning Letter deeming drugs adulterated, most of the time patients can continue to take adulterated drugs. So, to date, while Ranbaxy has never acknowledged that its adulterated generic drugs are linked to harm in any patients, but likely because of the investigation and resulting Consent Decree, they are now more apt to recall them.
Unfortunately, no adulterated Ranbaxy drug patients, including those identified by the nonprofit whose cooperation undoubtedly helped the government obtain the reported $500,000,000 settlement, are currently acknowledged as victims by the government. Instead, in the court of law, only the government and potentially, the Ranbaxy insider who blew the whistle are eligible for victim’s compensation and/or whistle-blower reward money. The end result is that the very individuals who may be harmed by taking adulterated drugs are often left to navigate an overly complex regulatory and legal system, and wind up shouldering some or all of the increased costs themselves. Jodi Ireland is one of those individuals.
“It’s so frustrating to think I never would have gone through all this if I hadn’t taken the generic Ranbaxy antibiotic. I’m so grateful to PME for figuring it out. They also helped me when my insurance company refused to pay for my IV treatments.
PME Investigates on Jodi’s behalf (click here for more)
PME Investigates on Jodi’s behalf
Jodi was on a long-term course of oral antibiotics because of the late diagnosis of a serious bacterial infection. She had been steadily improving, and her condition had stabilized when earlier symptoms suddenly returned along with debilitating headaches. Diagnostic tests showed that the infection was once again rampant and had spread to her brain and caused a lesion. She was put on IV antibiotics and gradually began to improve.
Suspecting that an adulterated generic drug may have been the root cause, PME contacted Jodi. After extensive examination to rule out other factors, it was discovered that shortly before Jodi’s symptoms escalated, her prescription antibiotic had been switched from a brand name to the Ranbaxy generic. This drug was later put on the FDA’s September 2008 list of banned drugs.
“I was in disbelief when they showed me the documents,” says Jodi. “So were my doctor and my pharmacist. It never crossed my mind that the medication could have anything to do with getting sick again. I just thought all generics were the same, only cheaper.”
The setback affected Jodi and her family on many levels
- She was very ill for over a year
- She needed daily IV treatments for over a year
- She needed surgery twice, to insert and remove an IV port
- The IV therapy affected her gall bladder, and she needed gall bladder surgery
- As the result of IV treatment, Jodi needed to use heparin. Some of Jodi’s heparin was contaminated, and she developed complications
- She must continue taking oral medication
- She is now high-risk and has fewer insurance choices and higher premiums and out-of-pocket costs
- She lost income because she was unable to effectively run her business
- She and her husband lost their home, due in part to her lost income
An update on Jodi
In 2011, Jodi had a recurrence of the infection and was also diagnosed with a co-infection. Because she received prompt treatment with unadulterated generic oral antibiotics, she only required a standard course of treatment. It reaffirmed to her and her doctor that not all generic drugs are created equally – the earlier Ranbaxy antibiotics that she took were adulterated and had never worked properly.
PME creates the Ranbaxy Victims Fund
On behalf of Jodi and other Ranbaxy patients and their families, in July 2012, PME formally requested that the Department of Justice set aside a portion -one to three percent of Ranbaxy’s criminal fines – from DOJ’s Victims Fund to help patients and their families. PME never received an official response from DOJ.