The government seemingly had a trump card in the negotiations the final approval for ranbaxy to sell generic lipitor. In october 2005, less than two months after his first contact, rivera-martinezs division sent a request to the division of field investigations to perform high-priority inspections at dewas, paonta sahib, and ranbaxys manufacturing division for raw ingredients, matrix labs. Furthermore, the fda noted that it was unclear whether the fda would even approve mylans application to sell the generic.
The company, now majority owned by japanese drugmaker daiichi sankyo, sells its products in more than 150 countries and has 14,600 employees. Hiv medications for the pepfar program from the troubled dewas plant to the newer paonta sahib facility in the hope that by severing links to the past fraudulent manufacturing and beginning to submit legitimate data on this group of drugs regulators would not detect the past misbehavior. The approval system requires the ethical behavior of the applicant, he said.
Fda inspectors were disturbed by what they found at the companys paonta sahib factory in india, where it planned to make generic lipitor. Ceo tempest had assured kumar that the company would do the right thing. It summarized the results of an inspection that who had done at vimta laboratories, an indian company that ranbaxy hired to administer clinical tests of its aids medicine.
In october 2008 the company purchased 12 boxes of a generic acne drug, isotretinoin, made by a competitor. For years, many of ranbaxys senior executives were expected to do what seemed like a small favor when they traveled to india carry suitcases full of brand-name drugs that they were told were needed for research and development. Ranbaxy shares fell 18 and took daiichi sankyos down 9 with them.
But its extent and depth and the involvement of top company executives have not been previously revealed. As the powerpoint stated, a short-term loss of revenue is better than a long-term losing proposition for the entire business. The company had a reputation for threatening people, bullying people, he recalls.
Much of the raw data didnt match what the company had filed with regulators. Says the fda spokesperson, the fact that there were some quality problems that led to a limited recall of the generic product was not a result of the approval process or how it was handled. Ranbaxy would admit that sotret was one of the adulterated drugs it had sold. Thakurs confidential whistleblower complaint, which he filed in 2007 and which describes how the company fabricated and falsified data to win fda approvals, was also unsealed. On april 24, 2005, thakur says, he presented ranbaxy with evidence of computer tampering and submitted his resignation.
None of us know where this is going to come out. The company even forged its own standard operating procedures, which fda inspectors rely on to assess whether a company is following its own policies. Posing as a company scientist and using broken english, he claimed that ranbaxy was forcing him to falsify data. Just before ranbaxys regulatory problems burst into public view, in june 2008, daiichi sankyo, japans third-largest drugmaker, purchased a majority share of the company. We have been waiting for your response for the last 2 months.
So it went with ranbaxy in a process that stretches back all the way to 2003 a time when the company was little known in the u. It created a pathway, the abbreviated new drug application (anda), which allowed a generic drug company to simultaneously challenge a patent and demonstrate to the fda that it could make a drug. It alleged that the violations at paonta sahib continue to result in the introduction of adulterated and misbranded products into interstate commerce with the intent to defraud or mislead. But four days later, as the company prepared to resubmit its arv data to who, the companys hiv project manager reiterated the point of the companys new strategy in an e-mail, cced to ceo tempest. Within a year the company was forced to start recalling its sotret again because the drug was degrading faster than it was supposed to the very problem that had been occurring before.
In india, thakurs job, as director of research information and project management, was to impose some order and transparency on the chaotic global pipeline. Arvs with fabricated data, i am confused how the usfda could give such an approval, thakur wrote to rivera-martinez. It contained each of ranbaxys markets and the substandard drugs the company had made. Some in the indian press portrayed the sale to a foreign company as a betrayal of national entrepreneurial pride. Due to complex logistics, foreign inspections can last less than a week and allow companies weeks of advance notice, while domestic ones can last up to six weeks and are unannounced. Department of justice, turned up disturbing evidence, according to government filings (though none of the resulting allegations related to lipitor). Asked about the decision to allow ranbaxy to make lipitor after its misconduct at two plants was revealed, an fda spokesman asserts that the agency is required to evaluate a drug application on a facility-specific basis. And then there was the ultimate shortcut using brand-name drugs as stand-ins for its own in bioequivalence studies. Noting ranbaxys agreement to manufacture brand-name drugs, a slide stated, we have also put our partners (bayer & merck kumar proposed a drastic course pull all compromised drugs off the market repeat all suspect tests inform regulators of every case of switched data and create a process for linking the right data to the right drugs. And indeed, thats precisely how it seemed until just a few months ago.India's Ranbaxy won the right to make a generic version of the $11 ... The war over Lipitor By Katherine Eban ... will go on sale for the first time in the ...