Can FDA ever safeguard China-made meds?

We all know that China has rocketed forward in the drug-manufacturing business, especially generics. Some 43 percent of plants applying last year to supply active ingredients for generic meds were located in China, versus a mere 13 percent in the U.S. And in recent months, as Big Pharma has faced unprecedented challenges to its bottom line, more and more branded drugmakers are turning to China, too.

But a big question mark still hangs over Chinese drugs and drug ingredients, as Gardiner Harris illuminates at length in this week's New York Times Magazine. China's plants and their output lack the scrutiny of manufacturing facilities in Europe, say, or the U.S. And even when the FDA finally opens its long-promised offices there, the vast numbers of factories churning out pharma-stuffs will still fall far behind on the oversight scale.

It's no surprise that, as Harris found, drugmakers just don't want to talk about the issue. No one wants to admit how difficult it is to regulate plants on the other side of the world. Nor is it surprising that the FDA "is increasingly beset by a sense of futility" when it comes to regulating foreign-made goods: not only chronically underfunded, understaffed and technologically primitive, the agency faces enormous cultural and bureaucratic barriers to doing its due diligence in China.

Not to say there isn't hope: For the first time in years, perhaps decades, there's a strong political will to get the FDA the resources it needs to protect the public from substandard drugs and drug ingredients. But cash-strapped drugmakers are sending their business to China at a faster and faster pace, so the agency will have to leap far forward to simply stand still. Whether Washington can deliver enough resources--and the FDA can work effectively enough--to keep up as pharma continues its headlong rush eastward is an open question.

- read the NYT story

Suggested Articles

Alnylam is ready to follow on its Onpattro launch with an FDA nod for Givlaari. But the drug's safety profile is giving analysts reason to pause.

FDA nominee Stephen Hahn faced questions from Senators on Wednesday on topics including drug pricing, biosimilars, opioids and more.

BMS’ Opdivo-Yervoy combo been game-changing in late-stage melanoma. But when it comes to expanding the pair’s reach, the company has hit a roadblock.