The Pharmaceutical Industry’s Turn Toward China

The NY Times Sunday magazine has published an interested if somewhat disconcerting article on China’s burgeoning role in the pharmaceutical industry. China’s booming economy has provided an opportunity for the country to become one of the world’s leading suppliers of pharmaceutical ingredients to make the drugs we consume here in the United States.
According to the article, China presently produces 2/3 of the world’s supply of aspirin and is poised to become the sole supplier in the not too distant future. Just last year, the FDA listed 1,154 plants providing the pharmaceutical ingredients to manufacture generic drugs. 43% of the plants are Chinese while 39% are in India. The US has a paltry 13% of the plants supplying these ingredients.
With profit margins squeezed, once skittish US pharmaceutical companies are turning to China to manufacture these ingredients. They can be made cheaper but we still don’t know if they’re safe since the FDA rarely inspects these foreign plants.
The other problem facing consumers and the FDA is the counterfeit drug trade. According to the Times Magazine article, it was estimated that in 2002 8% of the drugs in China are counterfeit. That number is presumably higher now given increased competition, the global economic crisis, and the demand for more drugs.
The US has already been affected by the consequences of this safety gap. The heparin scare earlier this year was the direct result of Chinese manufacturers substituting a cheaper counterfeit ingredient in order to manufacture heparin. The resulting deaths and sicknesses forced the FDA to ban the drug.
It’s not just contaminated or counterfeit drugs which cause concern. Recently, Chinese baby formula was linked to the tragic deaths of 4 Chinese babies and 53,000 others sickened by melamine, a toxic chemical that had been added to the baby formula to increase the protein count and trick quality control inspectors. The baby formula debacle never reached our shores but it did affect other countries. This is a problem that can’t be dismissed with facile explanations that it was contained to foreign countries. The prudent thinking has to assume that eventually a drug or consummable product will reach our shores and have disastrous consequences.
We need to do something about this Chinese safety gap. It’s not enough for the FDA to send over a few inspectors and set up a few FDA outposts in foreign countries. It’s a matter of national consumer safety that we know what’s being imported into our country. We can’t afford to take the risk in assuming these products are safe and effective. The pharmaceutical industry and the federal government must work together to regulate these manufacturing processes in order to keep us safe