Four Deaths and FDA’s Chinese Plant Mixup

Baxter International announced recently that it has temporarily halted production of heparin, a generic anti-clotting drug, because of four fatalities and hundreds of bad reactions potentially tied to the drug. Baxter and the FDA say they don’t know the exact cause of the bad reactions, but attention has focused on the active ingredient supplied by a Chinese facility.

This morning, Marc Kaufman reports in the Washington Post that this Chinese plant wasn’t inspected by FDA because the agency confused its name with another one:

Joseph Famulare, deputy director for compliance at the FDA’s center for drug evaluation and research, said yesterday in a conference call with reporters that when the company that makes the active ingredient for heparin applied for FDA approval, the FDA thought the application had come from a different company with a similar name that had already been inspected.

“To date this is an isolated situation, but the wrong firm was put into the database,” he said. Famulare declined to name the Chinese company approved by mistake.

The FDA mixup isn’t the only worrisome thing going on here. For one thing, Kaufman notes, federal law doesn’t require inspections of foreign drugmakers – although FDA officials told him that the agency will usually inspect before a new foreign drug or active drug ingredient is allowed in an FDA-approved prescription drug.

Another problem is that FDA is woefully under-resourced when it comes to inspecting the overseas facilities producing drugs and food for the U.S. The New York Times’ Gardiner Harris summarized the recent findings of a series of Government Accountability Office reports this way:

The Food and Drug Administration is so understaffed that, at its current pace, the agency would need at least 27 years to inspect every foreign medical device plant that exports to the United States, 13 years to check every foreign drug plant and 1,900 years to examine every foreign food plant, according to government investigators.

Computer systems at the drug agency are so inadequate that it can only guess the number of the plants, and it cannot produce a list of those that have not been inspected. The situation is particularly dire in China, which has more drug and device plants than any other foreign nation but where F.D.A. inspections are few.

So, it’s not really surprising that FDA failed to inspect the Chinese plant that was producing heparin’s active ingredient for Baxter. In fact, there are probably lots of Chinese plants producing drugs and drug ingredients that aren’t getting the oversight we’d like them to be.

This case also demonstrates just how dependent we are on Chinese manufacturers. Kaufman reports that millions of people are given heparin each year during dialysis or to prevent complications from surgeries, and just two companies, Baxter and APP Pharmaceuticals, make heparin for the American market. The active ingredient these companies use is made only China.

We’ve said it before and will keep saying it: Ensuring the safety of the drugs, food, and toys on U.S. shelves requires well-resourced federal agencies with significant enforcement authority. It’s an investment worth making.