Commissioner Margaret Hamburg and Congress are right to pursue with Chinese officials the making, regulation and tracking of APIs headed to the U.S. And one positive step has been the opening of FDA offices in Beijing, Guangzhou and Shanghai.
Efforts so far involve more coordination with Chinese officials than actual inspections work, reports the Wall Street Journal--a predictable first step. But proceeding at the pace of traditional West-meets-East relationship-building will not cut it here.
According to Guy Villax, a board member at the drug security trade group Rx-360, the bigger danger from pharma counterfeiting lies in counterfeit APIs (see report, "Top counterfeit drugs"). In his view, big-name counterfeits like Viagra are just the tip of the counterfeit-drug iceberg.
"There is a much larger volume, greater risk, in counterfeit APIs," he says in a phone interview. He sees growth in the number of traders that re-label less-than-pharma-grade substances--sometimes toxic--and enter them into the legitimate supply chain. Counterfeit APIs are often difficult to trace, given the many sources used by traders.
Recent cases of hazardous material showing up in drugs include the contaminated heparin case of 2007/2008, which led to hundreds of serious reactions and many deaths. And in 2006, some 400 people died in Panama after taking cold medicine made with deadly diethylene glycol disguised as glycerin syrup.
- here's the WSJ report