“No Tolerance” for Drug Manufacturers Fabricating FDA Data Doesn’t Mean Much

As I’ve written before, as a legal matter, drug companies have it easy. Consider what drug company lawyers called their ten “best” court opinions of the past year, many of which involved courts re-writing laws to dismiss lawsuits brought by injured patients. In the notorious PLIVA v. Mensing case, a 5-4 Supreme Court tried its hardest to wash away any claims injured consumers could have against generic drug manufacturers by ruling that, as a matter of law, any lawsuit would conflict with the FDA’s regulations — even though the Supreme Court couldn’t point to any actual conflicting regulations, and even though the FDA itself said there wasn’t a problem. That’s a big reason why commercials for Actos lawsuits and Pradaxa claims are so big now: they’re still patented, brand-name drugs.

Any hopes that consumers of generic drugs would be protected by the FDA’s own oversight of generic drug manufacturing came to a crashing halt earlier this week when the Department of Justice and the Food and Drug Administration jointly announced their Consent Decree with Ranbaxy Laboratories:

Through investigation by the department and the FDA, the government uncovered numerous problems with Ranbaxy’s drug manufacturing and testing in India and at facilities owned by its U.S. subsidiary, Ranbaxy Inc. These problems include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date.

The government also determined that Ranbaxy submitted false data in drug applications to the FDA, including the backdating of tests and the submitting of test data for which no test samples existed. All of these actions constituted violations of the federal Food, Drug and Cosmetic Act, making many of Ranbaxy’s drugs adulterated, potentially unsafe and illegal to sell in the United States.

As one member of the DOJ’s civil division said in the press release, “Submitting false data to the FDA in drug applications will not be tolerated.” These weren’t minor mistakes. It was a gross disregard for public safety covered up by deliberate falsifications to authorities.

And then we find out the penalty:

[T]he consent decree prevents Ranbaxy from manufacturing drugs for the U.S. market at certain of its facilities until those facilities can do so according to U.S. standards. To remove false data contained in Ranbaxy’s past drug applications and to prevent Ranbaxy from submitting false data to FDA in the future, the consent decree requires Ranbaxy to take actions such as:  hire an outside expert to conduct a thorough internal review at the affected facilities and to audit applications containing data from those facilities; withdraw any applications found to contain false data; set up a separate office of data reliability within Ranbaxy; and hire an outside auditor to audit the affected facilities in the future.

When it comes to the FDA and the DOJ enforcing federal law against drug manufacturers that poison the public and lie about it, “no tolerance” doesn’t mean, as one might assume, “zero tolerance,” or the handing out of automatic punishment for infractions. Instead, “no tolerance” merely means “please don’t do it again.”

I hope there are other pieces of the puzzle left to be filled in by the DOJ and FDA, and Bloomberg reported that “[t]he drugmaker set aside $500 million to resolve all potential civil and criminal liability related to the U.S. investigation,” which, I hope, will at least have made their outrageous and dangerous conduct unprofitable.

But let’s not overcomplicate things: if you or I submit false information to the government, we get prosecuted and we go to jail. If we recklessly endanger others, we get prosecuted and we go to jail. Cheat on your taxes? Drive drunk? You won’t be asked to sign an agreement not to do it again, you’ll go to jail. If corporations are people, then why can’t drug corporations and their officers be held to similar standards?

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