While catching up on reading, caught this interesting Q&A on Pharmalot: an interview with Rutgers business professor Michael Santoro (click here), who has just published a new paper on the subject of China's drug manufacturing safety: "Flight of the Toxic Dragon." Ed has also posted a poll where you can vote for or against pharma staying in China.
Professor Santoro makes some great points, but it would be extremely naive to believe that big pharma would ever pull out of the world's largest drug market (or facilitate its becoming fully state-owned and controlled). That is the "end game" for companies doing business in China. Outsourcing is just a prelude.
However, blaming a developing nation for failing to uphold QA and QC standards diverts attention from the real issue: variability in QA and QC oversight on the part of U.S. companies that outsource to China and failure to perform "due diligence" when outsourcing intermediate manufacturing to partners there. And please let's not blame the newly appointed and underfunded Food and Drug Policing Agency for the World, FDA. For a recent rant, click here.
AMS
