Bolster FDA inspections

Friday, April 25, 2008 | 2:04 a.m.

Now that there is strong evidence that contamination of the drug heparin occurred in China, pressure is rightly mounting on the Food and Drug Administration to expand its inspections of foreign pharmaceuticals.

From January of last year through last month, the FDA received reports of 131 people dying after being given heparin, a blood thinner. Most of the deaths 123 were reported after January of this year.

Eighty-one of the deaths, and hundreds of severe but nonfatal allergic reactions, have been directly linked to the contamination, which has led to widespread recalls of heparin in this country and many others.

The FDA reported this week that the contaminant is man-made, and that it has been traced to 12 companies in China.

At a House subcommittee meeting Tuesday, Rep. Bart Stupak, D-Mich., gave voice to the frustration felt across the United States.

“Last year this nation’s regulatory failures resulted in dead dogs and cats,” he said, referring to a contaminated ingredient made in China that was used in pet food widely sold in the United States. “This year it has tragically led to the deaths of people.”

Toxic toothpaste, contaminated fish and toys coated with lead paint have also made their way from China to U.S. markets in recent years.

In this latest scare, Chinese officials are not admitting any culpability. Nevertheless, the FDA says evidence points decidedly to China as the source of the heparin contaminant.

A bipartisan push is under way in Congress to provide the FDA with a budget that will allow it to greatly increase its inspections of foreign drug manufacturing plants. The Associated Press reports that the FDA conducted 30 such inspections last year, yet the agency lists more than 3,200 foreign companies that produce drugs for U.S. consumers.

We believe Congress should evaluate how many more FDA inspectors are needed and provide a budget to enable their hiring. More inspections would increase the chance of discovering contaminants before, not after, people die or become gravely ill.