Last week, Ranbaxy Laboratories agreed to pay $500 million to settle criminal and civil charges in the US for a serious and widespread manufacturing ruse. The feds called this the largest such penalty ever paid by a generic drugmaker for such violations. For nearly a decade, Ranbaxy perpetuated a scheme to boost profits and maintain its edge as a leading purveyor of low-cost generics. Scientists were ordered to manipulate reports; other employees were forced to illegally carry supplies of brand-name drugs to India and duplicitous statements were issued by high-ranking executives. The FDA, which later banned 30 Ranbaxy drugs from the US and reached a consent decree with the drugmaker, was alerted to the fraud by Dinesh Thakur, 44, who had worked for Bristol-Myers Squibb in the US and became a whistleblower after moving to India to work for Ranbaxy. He returned to the US seven years ago and will now collect $48 million, less attorney fees, for his role in helping the feds. We chatted with him about the fraud that he detailed in his lawsuit and the lessons learned from this episode. This is an edited version…
Pharmalot: So I read that early on, your son had an ear infection and you gave him a Ranbaxy drug, but it was ineffective. It was a foreshadowing, I guess, but what exactly happened?
Thakur: Children at that age develop ear infections and most often you prescribe amoxicillin and I got a pediatric dose, but nothing happened. That was the troublesome part. You trust the medication. You don’t question it, unless something stands out that makes you question it… So I (went back to the doctor) and the drug was switched for Augmentin, which is sold by GlaxoSmithKline and that made him better.
Pharmalot: As you looked into the various fraudulent activities, you saw a lot of disturbing things, which were outlined in the complaint (this story links to the complaint), but which of these worried you the most?
Thakur: The one thing that I can say is that working for any pharmaceutical company is that there are expectations for the drugs that are made and that the patients take. What I saw was a basic violation of the trust. There were a number of different things I saw and documented. But it all goes to the basic premise that you trust the medicine and if you can’t, there’s a big issue. But it was a combination of all of these things. I can’t single out one and say this was worse than another. When you think about all the things I saw and, it is in the complaint, each one by itself is an egregious thing (read more details here).
Pharmalot: From what I gather you went to the FDA (with your concerns), but not to the authorities in India. Why was that?
Thakur: No, I did not go to authorities there. I was educated in the US and worked in a US pharmaceutical company and I knew the FDA had the most understanding and knowledge of regulations and enforcement capability. And I just wanted to make sure that patients who were taking the drugs were not being harmed. And in my opinion, the FDA had the wherewithal to do that.
Pharmalot: What about the patients who took Ranbaxy drugs before the FDA instituted the ban or the consent decree was issued? They’re not really benefiting from this episode, are they?
Thakur: If you look back at the sequence of events that led to last Monday, with the Application Integrity Policy (see this), the FDA essentially eliminated 30 drugs from the supply coming into the US. Clearly, this was a benefit to patients in the country and was a positive consequence. And likewise, if you look at the consent decree, it has some onerous requirements of the company if it wants to sell drugs in this country again. As a consequence, I’m sure any drug sold in this country will be of a higher quality, assuming they follow through on their commitments. And if you remember, the FDA spokesman said they did not find any issue with the samples of those drugs.
Pharmalot: From what I’ve read, you hired private security for yourself and your family at one point after resigning from Ranbaxy and disclosing the fraud. Were you actually threatened, though?
Thakur: (He starts to respond, but his attorney, Andrew Beato, interjects by noting there “were 20 acts of serious reprisals against whistleblowers in India” in the recent past and “they have had deaths, because the idea of standing up to corporate malfeasance” is viewed differently.
Pharmalot: There were no individual Ranbaxy executives or managers who were singled out for penalties. Does that surprise or disappoint you?
Thakur: I can’t comment. What I did, whatever information I had, I gave to FDA investigators and they took it upon themselves to bring it to a conclusion. I don’t have any insight into the evidence that was used to bring something against an individual. I did what I had to do and it was up to FDA to work with that.
Pharmalot: Do you think one or more individuals should have been singled out?
Thakur: I don’t know why the government did what it did. I don’t have any insight into their decision making process, so it’s difficult for me to say that. What I saw here was so systemic and so pervasive that it goes beyond one individual so I really cannot comment on any whether one person or individual ought to be held accountable. That’s something the government ought to do with the evidence that they have.
Pharmalot: What lessons do you think others in industry ought to take away from this episode?
Thakur: When you talk about industry, things have changed. From the time I went to work for Ranbaxy in 2003 and now, if you look at the Food, Drug, Safety & Innovation Act passed last year, the FDA has more resources and inspection offices outside the country. And so it is able to respond to the global supply chain… It’s hard to react to something this large, but from what I can see, the FDA is doing what it can.
With the big sourcing from global locations, there has to be a process to verify the quality. There is a lot of focus on Cgmp violations.. The Justice Department came out earlier this year and said it will be an area of enforcement for them. The FDA global initiative is on track to address this problem. And Congress gave FDA resources to bring (overseas) manufacturing facilities on par with what exists in the US. I think we need to have strengthened rules so that companies know they are going to get caught…
The challenge in this particular case was because they knew they could get away with it. (At Ranbaxy), they knew ahead of time the FDA inspector was coming to Paonta Sahbi. If you take that comfort away, they will know they will be subject to the same standards before they do that kind of nonsense. But I’m very happy this has come out and … hopefully we’ll have safer medicines for people.
Pharmalot: And what about you? What will you do next? Work as a consultant or for a drugmaker? Will you work at all, given the settlement?
Thakur: I’ve learned a lot over the last years and clearly there’s an opportunity for me to share what lessons I’ve learned. I’d like to use the experience of the last eight years to get my point of view out there and hopefully work with companies that buy source ingredients from China and India and make sure the quality we want is what we get.
At the moment, I haven’t really narrowed it down. Probably working as a consultant would be something I’d look forward to… This wasn’t about money. When you think about it, for two years, I worked with FDA, but not because there was a pot of gold at the end of the rainbow. That was not a driver. If money was a driver, I would have taken a different route. If I believe the lessons I’ve learned can help the quality of the drug supply, I think it’s something I should be doing…
Pharmalot: You’re not going to write a book?
Thakur: I haven’t gotten that far. But I did just start a small blog.