OUTSOURCING MEDICATIONS TO CHINA

The other day I was catching up on some reading of piles of magazines which had been accumulating dust and found this.

Excerpt from an October 5, 2007 article in U.S. News & World Report:

...Gone are the days when Americans could unquestioningly trust in the quality and authenticity of their pharmaceuticals. So far, no American deaths have been linked to shoddy or fraudulent medications. But a surge in hazards discovered at home and abroad has cast new doubts on the safety of prescription and over-the-counter drugs, supplements, and other medical products. Americans "should be quite concerned," says Roger Williams, CEO of US Pharmacopeia, a private organization that creates the nation's official quality standards for drugs.

Americans still have the best pharmaceutical products in the world, says Williams. But the safety net is getting frayed. Recent problems with other goods imported from China, such as the melamine that tainted pet food and killed dozens of dogs and cats, and toothpaste made with diethylene glycol, have sparked worry that the pharmaceutical industry's rapid migration to manufacturing plants in China and other Asian countries is increasing the risk of similar problems with medicines.
In the past five years, Chinese pharmaceutical imports into the United States have more than doubled, to $698 million. Already, half of the aspirin used worldwide comes from China, as do 35 percent of the painkiller acetaminophen and almost all synthetic vitamin C. India's pharmaceutical imports into this country increased 2,400 percent, to $789 million, from 1996 to 2006, making it the fastest-growing drug importer. Last year, Indian firms won Food and Drug Administration approval to import more than 100 generic drugs, including a version of the anti-HIV drug Retrovir. India and China make about 20 percent of generic and over-the-counter drugs sold in the United States and at least half of the "active pharmaceutical ingredients" for pills made within the United States. "Ten years ago, the Chinese and Indian API market was nonexistent, and now they're dominant," says Lynne Jones Batshon, executive director of the Bulk Pharmaceuticals Task Force, a group of ingredient manufacturers. Price is a key driver of that shift, Batshon says, and complying with American regulatory requirements is expensive.

At the moment, consumers have no way of knowing where their drugs are produced or assembled, because there are no requirements for country-of-origin labeling of drugs....[C]ounterfeit diabetes test strips were traced to a firm in Shanghai. And when at least 56 people died in Panama last fall after taking cough and allergy medicines, it was discovered that the drugs had been spiked with toxic diethylene glycol sold as harmless glycerin by a Chinese firm. Raw ingredients and finished products can move through a half-dozen countries before landing on a pharmacy shelf.....

[...]

Even brand-name drugs you buy at the local pharmacy may pose dangers. Counterfeiting, says Hubbard, is extremely profitable and "a lot easier than selling narcotics. And you don't have to deal with a Colombian drug lord." The World Health Organization estimates that 10 percent of pharmaceuticals worldwide are counterfeit.

Turns out that the above is not old news. Along comes this item in the November 2, 2007 Washington Post:

FDA Unsure It Inspected Foreign Drugmakers

Two-thirds of the foreign drug manufacturers subject to inspection by the Food and Drug Administration may never have been visited by agency inspectors, a government watchdog reported. The FDA this year listed 3,249 foreign pharmaceutical manufacturers subject to its inspection -- yet the agency cannot determine whether it has inspected 2,133 of them, said a Government Accountability Office report released during a House subcommittee hearing.

As we Baby Boomers age and require more and more pharmaceutical intervention, this outsourcing of medications and the ingredients therein could pose a significant problem, maybe even a significant danger.