According to a story from The People’s Pharmacy, there are an increasing number of worrying stories and incidents that are calling into question the US Food and Drug Administration (FDA)’s ability to conduct effective oversight in regards to the safety and quality of generic drugs. Generics are essentially a cheaper version of a popular brand name drug that can be legally produced once the patent expires on the original. Nearly 90 percent of the drugs that US citizens use are generics, but it is steadily becoming clear that the FDA should be taking more regulatory action to keep patients safe.
An investigation from Bloomberg News paints a dire picture of the state of generic drug regulation. Here are links to some of the related stories:
America’s Love Affair With Cheap Drugs Has a Hidden Cost
How a Tainted Heart Drug Made in China Slipped Past the FDA
Culture of “Bending Rules” in India Challenges US Drug Agency
Keeping Patients Safe?
To summarize the situation around generic drug regulation, it is only a slight exaggeration to say that it doesn’t really happen at all. The FDA simply relies on data submitted by the manufacturing companies and trusts that everything they send the agency is true. The agency does very little testing of generic drugs itself.
When operating a manufacturing business, the goal of such as business is to manufacture a product as cheaply and efficiently as possible and sell said product for as high a price as customers are willing to pay. This incentivizes businesses to cut corners as much as possible. Sometimes this has little effect and is mostly beneficial for the business without harming the consumer or degrading the quality of the product. However, there are some corners that shouldn’t be cut, especially when the product is something that a person is relying on to stay alive.
The agency has repeatedly said that it depends on the ethical behavior of manufacturers to maintain standards:
“We depend on that information to be truthful. The approval system relies on the ethical behavior of the applicant.” – Gary Buehler, former head of the Office of Generic Drugs at the FDA
This reliance on ethical behavior is, regrettably, naive.
Take the story of Mylan, the second largest generic drug manufacturer in the US. A whistleblower tipped of the agency of suspicious activity there and FDA investigators descended. They discovered a heap of shredded quality control documents (that were supposed to be saved) and many other violations. It was suspected that the company had passed drugs for use that fell short of quality standards.
The punishment for Mylan? Nothing. They were simply asked nicely to fix the problems. The fact that the agency must rely in whistleblowers to inform it of quality problems should be a major cause for concern. After all, being a whisteblower in the pharma industry means a swift end to your career.
One of the largest recalls in the agency’s history also occurred recently when large numbers of heart and blood pressure medications from China had to be rejected due to possible contamination with a carcinogen.
Is the generic drug that you are taking now going to give you cancer? Probably not, but it doesn’t change the fact that the FDA simply is not doing its job by taking the world of generic manufacturers at face value no matter what. And then failing to punish them when they get caught lacking? Really not acceptable.
