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Generic Drugmaker Makes Potentially Dangerous Product, Sues FDA for Slowing Its Sale

December 17, 2014

This blog has been covering issues related to generic drugs–warning labels, FDA oversight, and legal immunity–for more than a year, but this industry is nothing if not persistent. One of the largest manufacturers of generic pharmaceuticals in the world–Ranbaxy Laboratories, with net revenue of $2 billion in 2012–has provided material that lends itself to an infuriating follow-up story (thanks to for covering this, as well).

As we have pointed out in previous articles on the subject, the generics industry runs almost entirely on the honor system. After a drug makes it to market, the FDA leaves product safety to the manufacturer. In other words, there is almost no screening, monitoring, regulation, or oversight conducted by the FDA on products it has already approved. If a consumer wants to report a generic medication as dangerous, they must contact the corporation responsible for making it, who is then supposed to alert the FDA. But, believe it or not, this does not always happen as it should.

In 2011, the United States Supreme Court decided that while a pharmaceutical manufacturer is responsible for errors and omissions in its products’ safety warnings and labels (and may be held responsible for them), companies making cheaper generic versions of the same drugs are not. This decision created what is now known as “umbrella” or “blanket” coverage; as long as pharmaceutical companies making generic drugs do not alter medications or warnings, they are completely immune.

Ranbaxy, the generic giant mentioned above, makes off-brand versions of two hugely popular products, AstraZeneca’s Nexium (a heartburn drug) and Roche’s Valcyte (an antiviral drug), but a whistleblower a few years ago alerted authorities that the company had falsified reports presented to the FDA. Even then, it took years for the FDA to get involved. In late November, the FDA decided to rescind its approval to distribute these two drugs, and within days Ranbaxy announced it would be suing the FDA for “violating its constitutional rights and stripping it of hundreds of millions of dollars in potential revenue.” Bloggers at ThePopTort point out that this eagerness to sue stands in stark contrast to current legislation concerning generic drugs.

It seems unconscionable that pharmaceutical companies have the ability to sue a government agency for keeping their potentially deadly drugs off shelves. But even more than that–given the “blanket” immunity policy makers of generic drugs enjoy–consumers do not have recourse through the courts to be made whole when they are harmed by such medications. To emphasize the double standard here, there are no similar laws protecting brand-name pharmaceutical companies, only generics.

Another shocking turn in this case is that the FDA very recently agreed to delay its decision based upon petitioning from the Generic Pharmaceutical Association (whose board includes a Ranbaxy vice president); instead of making a decision before the year’s end, the agency has granted itself the better part of 2015 to review the case. An attorney for the consumer watchdog group Public Citizen further explains that while this may seem like a headline-grabbing stunt on the part of Ranbaxy, it may have a negative effect on consumers: “The extra nine months or so of delay allows a safety gap to continue that can only lead to harm. […] The sooner generic drug companies are allowed to make safety updates, the better for public health.”

A case like this shows us how tenacious, vigilant, and persistent citizens, consumer advocates, and attorneys must be in order to protect individuals from corporations (with limited help from government regulators) whose main concern is the bottom line, sometimes at the expense of patient safety.


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