Don't let counterfeit drugs flow into America

Forum Communications Company
By Robert Goldberg
February 08, 2008

NEW YORK - Millions of American parents are understandably nervous about the risks that toys and other goods manufactured overseas may pose to their children. Politicians have thundered about screening imports, particularly from China, more carefully.

And yet, many lawmakers continue to call for the importation of goods that could be far more dangerous - prescription drugs. They want to force American drug companies to let foreign manufacturers sell versions of their drugs made for foreign market in America, claiming it will bring down drug costs for consumers.

They also claim that the Food and Drug Administration will be able to inspect foreign manufacturers and distributors to ensure that only products using FDA-approved ingredients, processes and anti-counterfeiting technologies will get into the country.

We've heard that before with respect to toys and pet food.

Let's look at how Congress has handled China, the main source of the problem. The World Health Organization estimates that 10 percent of world's drugs are counterfeit. Although precise figures don't exist, it is widely believed that more of them come from China than any other country.

Many of these Chinese-made knock-offs are dangerous, even deadly.

The Chinese government has known this since 1996, when 85 children in Haiti died from taking a medicine that contained a lethal ingredient, diethylene glycol, which was made by a Chinese chemical company.

This company broke the law; China's State Food and Drug Administration had never certified it to manufacture drug ingredients. But Chinese authorities didn't sanction the manufacturer, nor did they adopt any regulations to prevent something similar from happening again.

So it did happen again, last year. More than 100 Panamanians died after taking a cold medicine that contained the same poisonous ingredient. It, too, was made in China, by another uncertified company.

In the wake of this incident, Chinese regulators said they would crack down on counterfeiters and uncertified chemical companies. But they haven't followed through.

The pushers of the sick importation scheme - Sens. Olympia Snowe, R-Maine, and Byron Dorgan, D-N.D. - claim it would ban all drugs from China. But China's drugs flow freely to Canada, which is exempt from the inspection regimen they would require of other countries.

Worse, China is the source of the ingredients of the pills Snowe and Dorgan would allow in and force the FDA to certify as safe.

Of China's estimated 80,000 chemical companies, the nation's State Food and Drug Administration hasn't opened an investigation into a single one (since it claims that it does not regulate these firms). Hence, dozens of uncertified chemical companies proudly and publicly plied their wares at a pharmaceutical trade show in Italy earlier this year.

Meanwhile, the FDA's oversight of foreign drug makers who export to the U.S. is woefully inadequate. According to the Government Accountability Office, there are 3,249 foreign drug manufacturers subject to the FDA's jurisdiction, and the agency can't even tell whether it has inspected 2,133 of them.

Nor does it know how many of them are exporting drugs to this country, or what drugs they might be.

While U.S. drug makers receive at least one visit from FDA inspectors every two years, only 14 percent of foreign manufacturers are inspected in the same time frame. By the GAO's calculation, this means that more than 13 years could pass before a foreign drug maker gets its first FDA inspection.

Responsible politicians would regard drug importation as unwise, particularly under these circumstances. Unfortunately, by pushing for prescription drug imports, it appears that our lawmakers will be doing little to protect us from the dangers of counterfeit drugs in the new year.

Goldberg is vice president of the Center for Medicine in the Public Interest.