U.S. drug makers buy ingredients from unregulated Chinese companies
Chinese drug companies are supervised — whatever that means in China — by China’s regulators; there are 80,000 chemical companies in China, but they do not come under the jurisdiction of China’s drug regulators; trouble is, these unregulated, uncertified companies sell ingredients of uncertain quality to U.S. drug makers
Do you know what ingredients your medications contain? Do you know where these ingredients come from? Pray they do not come from China. When you cover homeland security stories, you cover many scary things. One of the scarier stories we read was about the how Chinese chemical companies — unregulated, unsupervised, operating within a system with no safety standards — sell chemicals to Western pharmaceutical companies to be used in the manufacturing of drugs. The New York Times’s Walt Bogdanich, Jake Hooker, and Andrew Lehren write a devastating — and thoroughly chilling — report about this trade. Here is a couple of paragraphs:
“…Pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators, the New York Times has found.
“Because the chemical companies are not required to meet even minimal drug-manufacturing standards, there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients. The substandard formulations made from those ingredients often end up in pharmacies in developing countries and for sale on the Internet, where more Americans are turning for cheap medicine.”
The general source of the problem is China’s lax, or non-existent, safety and health standards. The more specific source is that while pharmaceutical companies are regulated by the food and drug agency (leaving aside for now the quality of this regulation), chemical companies that make products as varied as fertilizer and industrial solvents are overseen by other agencies. The problem arises when chemical companies cross over into drug ingredients. China’s health officials have known of this regulatory gap since at least the mid-1990s, when a chemical company sold a tainted ingredient that killed nearly 100 children in Haiti. Chinese regulatory agencies have failed to cooperate to stop chemical companies from exporting drug products. In 2006 at least 138 Panamanians died or were disabled after another Chinese chemical company sold the same poisonous ingredient, diethylene glycol, which was mixed into cold medicine.
U.S. citizens are exposed to the same risks to which those poor Haitians and Panamanians were exposed. Trouble is, China has an estimated 80,000 chemical companies, and the U.S. Food and Drug Administration (FDA) does not know how many sell ingredients used in drugs consumed by Americans.
