Ranbaxy is a huge generic-drug maker – the sixth largest in the country, with more than $1 billion in U.S. sales. But as the Center for Justice & Democracy noted in its report, “America’s Unaccountable Generic Drug Industry,” Ranbaxy also has a history of fabricating data, lying to regulators and forging documents. I guess that’s one way to make money.
A Fortune Magazine investigation, which uncovered the full extent of Ranbaxy’s recent misconduct, noted how Ranbaxy’s behavior illustrates some “generic” things about the generic drug industry:
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 2009…. The approval system “requires the behavior of the applicant,” he said. Otherwise, “the whole house of cards will fall down.”
The FDA hasn’t exactly been on top of these problems. It took a whistleblower coming forward to prove that Ranbaxy lied to the FDA and falsified data. Even then, it took years for the FDA to stop approving the compromised Ranbaxy drugs. In other words, the FDA is not exactly this industry’s nemesis. Ironically, as soon as the agency tried to exercise some kind of control over Ranbaxy, the company decided – wait for it – to sue the FDA! Writes the Wall Street Journal:
Just days after the FDA rescinded tentative approval for Ranbaxy Laboratories to sell generic versions of two widely used medicines [Valcyte antiviral sold by Roche and the Nexium heartburn pill marketed by AstraZeneca], the drug maker has filed a lawsuit accusing the agency of violating its constitutional rights and stripping it of hundreds of millions of dollars in potential revenue.
You see, Ranbaxy believes it has a constitutional right not only to make money but also to sue to enforce that right. But anyone killed or injured by unsafe Ranbaxy drugs? They should have no legal rights at all, apparently.
That's the position of the Generic Pharmaceutical Association, on whose Board of Directors Ranbaxy’s Vice President, Chuck Caprariello, sits. The GPhA is fiercely opposing a new FDA rule that would get eliminate the legal immunity that generic companies recently received (courtesy of the U.S. Supreme Court) for killing or injuring their customers. The FDA is trying to fix a regulatory loophole that allows a generic drug manufacturer to maintain a label even if it knows that label to be inaccurate and out-of-date. And because generic companies currently have no power to make those changes, they cannot be held liable if a consumer is harmed or killed by a generic drug due to the drug’s inadequate labeling or defective design. In other words, the injured patient has no recourse. Yet, if the patient happens to take a brand-name version of the drug instead and is injured, the patient does have recourse! I mean, even the Court majority suggested this result was “bizarre” (their word), pointing out, “Congress and the FDA retain the authority to change the law and regulations if they so desire.” Many organizations and even the New York Times have implored the agency to implement this common sense rule change.
But the GPhA just got the agency to delay this rule for almost an entire year. The rule was supposed to be finalized next month. Writes the Wall Street Journal:
By proposing the rule, FDA officials have previously explained they want to “create parity” between brand-name and generic drug makers. Since the passage of the 1984 Hatch-Waxman Act, generic drug makers have not been required to run tests to prove their medicines are the same as brand- name drug and, therefore, have not had to upgrade labels with safety information.
One consumer advocate was chagrined to hear of the delay. Allison Zieve, who heads the litigation group at Public Citizen, which had petitioned the FDA to revise its generic labeling rules, says the additional time for review is not good news for consumers.
“The extra nine months or so of delay allows a safety gap to continue that can only lead to harm,” she tells Pharmalot. “No drug is safe in all situations. A drug is safe when used in accordance with labeling that accurately reflects the known risks. The sooner generic drug companies are allowed to make safety updates, the better for public health.”
I don’t know which is worse: the audacity or the hypocrisy.