FDA Without Borders
In early March, it was reported that SFDA was being downgraded and placed under the control of the new, massive Ministry of
Health, which will set drug and food safety policies.
Meantime, FDA head Andrew von Eschenbach scrambled to answer his congressional critics by announcing FDA Without Borders,
a plan to base FDA inspectors and technical advisers in China, India, the Middle East, and three other regions. He also requested
a permanent FDA presence at the US embassy in Beijing and two US consulates in China.
And among a flurry of legislation, the most likely to gain traction is a bill sponsored by Democratic Senators Charles Schumer
(NY) and Edward Kennedy (MA) to jack up FDA funding to increase inspections of foreign drug factories. Still, insiders like
Sheldon Bradshaw remain skeptical. "The agency will still be woefully underfunded," he says. "Dealing with the hypocrisy of
Congress was the most frustrating thing about my tenure as chief counsel. They constantly complain about FDA failures but
handcuff the agency by not appropriating sufficient resources."
It remains to be seen what fate will befall whoever is behind the lethal fake heparin. China is know to execute drug counterfeiters
whose victims are Chinese while entirely overlooking those responsible for killing foreigners. But with the Ministry of Health
in charge and the Olympic on deck, the heparin investigation is likely to break that pattern.
As for pharma and China, CEO Guy Villax's longtime experience keeps him bullish. "China offers an excellent environment for
world-class manufacturing," he says. "But because enforcement is inadequate, many rogue players have the opportunity to make
vast margins—especially in generic drugs—by putting the lives of patients at risk."
His firm, Hovione, last month purchased 75 percent of Hisyn Pharmaceutical, with development labs in Shanghai and a huge API
plant nearby. "Squeeze the price, and you push suppliers into cutting corners and providing substandard product," he says.
"But if you encourage high standards and support increased costs, you can expect to collect in a later harvest."