Overseas drugmaking goes unsupervised

Look no further for a couple of gaping holes in our drug-safety fabric. Chinese regulators may be cracking down on some drug-safety violations, but plenty of chemicals companies aren't even being watched. Stateside, the FDA is struggling to track foreign drug makers--and that not very successfully.

First, the Chinese chemicals firms. According to a New York Times investigation,they're making pharmaceuticals ingredients, but many aren't certified or inspected by the government. They aren't required to meet any drug-manufacturing standards. Some even make finished drugs without any supervision whatsoever. And dozens of them--including known counterfeiters and poison-passers--came to a pharma trade show to sell drug makers on their products.

Next, the poor, underfunded FDA. According to a Congressional memo obtained by the Wall Street Journal, the agency can't even keep track of how many foreign drug makers it should oversee. And those it does know about are inspected only once every 8 to twelve years. Problems with foreign oversight were identified a decade ago--but they're still uncorrected. This at a time when drug and ingredient imports are skyrocketing. Agency officials say they do know who's importing drugs to the U.S. and that they focus inspections on products that pose the greatest risk. But they admit funding is down, and so is staffing.

- check out the NYT article on unregulated Chinese manufacturers
- read the WSJ report about FDA's lack of foreign oversight

Suggested Articles

The FDA has granted Amarin's Vascepa a possible blockbuster label expansion for CV risk reduction in patients with or without CV disease.

In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. 

It’s been a year of ups and downs for Pfizer’s Xeljanz. But the company is hoping to close on a high note, with help from a new extended-release pill.