Those Generic Drugs May Not Have Been What You Thought They Were


Those Generic Drugs May Not Have Been What You Thought They Were
by Megan McArdle

May 17, 2013 10:52 AM EDT

Complaining that generic drugs from abroad are nothing but cheap fakes has long been a staple of free-trade opponents, and of course, pharmaceutical manufacturers trying to protect their products from foreign competition. While it’s long been clear that there was some truth to the horror stories–don’t buy drugs on the internet, okay?–I’ve been pretty dismissive of complaints about Indian generics giants like Ranbaxy and Cipla. These guys are huge companies with brands to protect. Moreover, they’re inspected by the FDA. Why would they risk it all by adulterating their product?

Now, in the case of European pharmaceutical manufacturers, who are already under the supervision of their own quite strict regulatory agencies, that doesn’t really matter. But when it comes to drugs from countries with weaker regulatory regimes, it seems clear that it does. Yes, Ranbaxy eventually got caught. But for years, they sold drugs of uncertain quality. It’s hard to say how many people they killed, but it’s unlikely that the number is zero, or even near-zero.

It’s possible that we should rethink our willingness to approve drugs from companies who can’t be inspected the way rich-world firms are. Yes, I have my problems with the FDA approval process, but even many libertarians are fine with this basic part of the FDA job: making sure that the drugs people are selling contain the ingredients they claim, at the concentrations written on the package. It seems that they have a hard time doing this job with firms in foreign countries. And it took a very long time for the FDA to get tough with Ranbaxy, despite evidence of repeated violations.

There’s another aspect to this that McArdle didn’t mention. Since at least the 70s, consumerists have touted generics as a solution to profiteering by EEEEEEEEEEEEEE-vile Big Pharma. That created enormous pressure on the FDA to ease the approval process for generics. And post-approval quality checks? chirp … chirp … chirp … The FDA needs to understand the difference between responsiveness to public need and cornering cutting and exploitable processes that encourage fraud and endanger the public. And, maybe, just maybe, discriminate between producers of generics that operate in a quality-regulated environment and producers that face few or no controls on fraud and quality?