Is America relying too much on medicine from abroad?

Consumer Reports News: January 23, 2009 05:56 PM

Over the years, I’ve reported extensively about prescription drugs – why they cost so much, where to find the best deals, which pharmacies offer the most knowledgeable and helpful advice, how to avoid serious interactions, the dangers of rogue Internet pharmacies, the pros and cons of sleeping pills, and so on.

But the article I read by Gardiner Harris in Monday’s New York Times addressed a subject most of us probably haven’t paid enough attention to – how more and more of our nation’s prescription drugs are being made overseas, particularly in China.

By now, you’d have to be living under a rock not to know that China is the source of many staples American consumers depend on – TV sets, computers, clothing, appliances, jewelry, toys, pet food, you name it. It’s difficult to know precisely how much comes from China because many products labeled “Made in America” contain ingredients or components from that country. But I can tell you it’s a lot: According to a 2007 report prepared for members of Congress, total trade between the U.S. and China surged from $4.9 billion in 1980 to an estimated $343 billion in 2006. Over the same period, America’s trade deficit with China soared from $10.4 billion to $232 billion.

Last January, we published a report on the growing problem of counterfeit goods flooding the U.S., most of which come from China. In fact, an estimated 81 percent of all fakes, including drugs, emanate from China, according to the Department of Homeland Security.

The explanation for the decline of the domestic drug industry pretty much mirrors the explanation other industries offer when asked why they’ve shifted production to plants in Asia: Cheaper labor, construction, and environmental costs. There’s also far less oversight, a critical part of assuring a safe and secure drug supply. One reason drug makers moved abroad is that the Food & Drug Administration inspects domestic facilities much more often than foreign ones, making production more expensive in the U.S.

The Times article noted that the critical ingredients for most antibiotics are now made almost exclusively in China and India, with the same holding true for dozens of other crucial medicines, such as prednisone (used to treat autoimmune and inflammatory diseases); metformin (diabetes); and amlodipine (high blood pressure).

And since the 1980s, the article continues, the Chinese government has been investing huge sums in penicillin fermenters, “disrupting prices around the globe and forcing most Western producers from the market,” according to a global expert quoted in the story. Another expert warned that if China quit supplying pharmaceutical ingredients tomorrow, “the worldwide pharmaceutical industry would collapse.” And “if China ever got very upset with President Obama, it could be a big problem.”

That can’t be comforting news to the U.S. or the rest of the world, for that matter.

The Centers for Disease Control and Prevention has a stockpile of medicines with enough antibiotics to treat 40 million people, but if more medicine is needed, the nation simply doesn’t have the plants to produce them, and it would take two years to start from scratch, the article noted.

Sen. Sherrod Brown, an Ohio Democrat, who has held hearings on the issue of overseas drug manufacture and importation before the Health, Education, Labor, and Pensions committee, said in a position statement, that the FDA has very little capacity to ensure the safety of imported medications. “It has become too easy for any unregulated manufacturer to ship tainted goods straight to our country’s grocery stores and pharmacies,” he warned.

I interviewed a spokeswoman for the Senator on Thursday, who said that Brown has little confidence the FDA can police foreign factories because agency has a “major shortage of inspectors.” Brown believes the cost of additional inspectors should be borne by drug makers that choose to do business overseas, and he intends to push for that.

Along similar lines, Consumers Union, parent of Consumer Reports, is working with Congressional leaders on a bill that would require the FDA to provide tighter scrutiny of foreign drug-making operations and imported medicines destined for the U.S. market. The legislation also would require foreign drug manufacturers and suppliers to be registered (in some instances, the FDA isn’t even aware of who’s making what), and permit the inspectors to make unannounced plant inspections at least every two years. The current level of inspections is 10 or more years in some countries.

Marc Perton

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