A Fortune report on the Indian drug company Ranbaxy, sixth largest generic drug manufacturer in the world and currently owned by a Japanese company, is unsettling reading.
On the settlement and the broader context for the problems:
On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn’t meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties — the most ever levied against a generic-drug company. (No current or former Ranbaxy executives were charged with crimes.) Thakur’s 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. Under federal whistleblower law, Thakur will receive more than $48 million as part of the resolution of the case.
Fortune’s account of what occurred inside Ranbaxy and how the FDA responded to it raises serious questions about whether our government can effectively safeguard a drug supply that last year was 84% generic, according to the IMS Institute for Healthcare Informatics, much of that manufactured in distant places. More than 80% of active pharmaceutical ingredients for all U.S. drugs now come from overseas, as do 40% of finished pills and capsules.
A good warning:
Fortune’s investigation yields the first comprehensive picture of how one under-policed and far-flung generics company operated. It is not a tale of cutting corners or lax manufacturing practices but one of outright fraud, in which the company knowingly sold substandard drugs around the world — including in the U.S. — while working to deceive regulators. The impact on patients will likely never be known. But it is clear that millions of people worldwide got medicine of dubious quality from Ranbaxy.
And why the system doesn’t work:
As the Ranbaxy story makes vividly clear, generic-drug makers intent on breaking the rules — especially those operating abroad — can easily do so. Drug applications work on the honor system: The FDA relies on data provided by the companies themselves. “We depend on that information to be truthful,” Gary Buehler, who headed the FDA’s office of generic drugs for 10 years, said in December 2009. (Buehler has since taken a position at the U.S. unit of the Israeli generic-drug company Teva.) The approval system “requires the ethical behavior of the applicant,” he said. Otherwise, “the whole house of cards will fall down.”
And how the U.S. government helped Ranbaxy make enough in 6 months to pay its above-mentioned “huge” fine:
Despite the agency’s finding of fraud and misconduct, it granted Ranbaxy lucrative rights to sell new generic drugs. In the most high-profile example, in November 2011 the FDA allowed the company to maintain its exclusive first dibs on making the generic version of a medicine taken by tens of millions of Americans: Lipitor. In the first six months, this privilege allowed Ranbaxy to generate $600 million in sales of generic atorvastatin, as nonbranded Lipitor is known.