Inspection gap poses risks

Saturday, Oct. 25, 2008 | 2:06 a.m.

Investigators attached to a House subcommittee last year reported that the Food and Drug Administration’s budget for inspecting foreign manufacturers of prescription drugs sold in the United States would be lower in 2008 than it was in 2002.

This was alarming because the amount of drugs and drug ingredients being imported into this country has been greatly expanding every year. It didn’t make sense, then, that the federal budget for inspecting the source of those drugs had been declining every year.

The seriousness of the news was brought home in a tragic way. This spring the FDA confirmed that a tainted blood-thinning drug imported from China had been the cause of dozens of patient deaths over the past several months.

At a hearing in November before a House committee, FDA Commissioner Andrew von Eschenbach testified at length about the existing standards for imported drugs and the technical improvements his agency was making to increase their safety.

But in stating that his agency “performs over 200 foreign drug manufacturing inspections per year,” he was acknowledging the inadequacy of that number. According to a report released Wednesday by the Government Accountability Office, and reported by the Associated Press, there are at least 3,249 foreign drug manufacturing plants that make medications for the American market.

The report pointed out that pharmaceutical factories in the United States get a federal inspection, on average, every 2.7 years. It is important that foreign drug manufacturers exporting drugs to this country, and domestic drug manufacturers, be inspected at similar frequencies, the report concluded.

We agree, particularly since von Eschenbach’s testimony had also included this statement: “The safety of products from China, as well as other trading partners, remains a concern for ... our staffers, Congress and American consumers ... We have limited knowledge of the quality of ingredients and products manufactured in China, as this fast-growing source is just beginning to put in place a national regulatory infrastructure.”

It should be a priority for Congress and the next president to agree on a plan that will result in the FDA getting sufficient funding to increase its foreign inspections.