Should we ‘just say no’ to drugs made in China?

In a global economy, who’s to keep you from ingesting a little diethylene glycol with your cold medicine?

The New York Times raised the question in an extensive report last week on the regulatory voids that allow Chinese chemical companies to produce and export substandard (and sometimes downright poisonous) drug ingredients.

It points to two tragic cases since the 1990s that killed or disabled hundreds in Haiti and Panama, when drugs using Chinese-made ingredients ended up containing diethylene glycol, a toxic solvent used in antifreeze, among other things.

The problem isn’t necessarily with China’s pharmaceutical companies (China National Pharmaceutical or China Shineway, to name two) because they are regulated by the country’s food and drug agency. But there are some 80,000 chemical companies in China that aren’t regulated by that agency, and many of them produce active pharmaceutical ingredients (API) used to produce finished drugs.

Nothing so awful as the Haiti and Panama tragedies has occurred in the US, which is perhaps the safest pharmaceutical market in the world. But that doesn’t mean there’s no reason for Americans to be concerned.

First of all, Big Pharma has signaled its intentions to outsource more API manufacturing to China and India, with AstraZeneca being the most recent drug giant to make news on that score. A sound regulatory structure needs to be in place to allow that to happen safely.

Secondly, drugs with unregulated Chinese ingredients routinely make their way into the US via Internet pharmacies hawking counterfeit drugs.

And third, even the Food and Drug Administration, with all its regulatory muscle, isn’t currently capable of inspecting foreign drug makers with the rigor and frequency necessary to insure the safety of American imports. A Congressional sub-committee heard testimony from the GAO on Thursday to that effect.

Congress heard similar reports about the FDA 10 years ago and not enough has changed since then. But with the pharmaceutical world finally waking up to the cost-efficiencies of outsourcing, now might be a good time to make a change or two.