Might the heparin contamination scandal be an object lesson in the brave new world of pharma? After all, the drug isn't alone in being made from ingredients manufactured in the developing world, i.e. China, India, and elsewhere. It's not alone in being vulnerable--because of its lengthy supply chain--to contamination.
And the drop-in-the-bucket solutions FDA and others have suggested--such as dispatching eight full-time employees to China--simply underscore how much the globalized world differs from the good old easy-to-oversee days. "We have become a global economy and we are regulating with a domestic mindset," Eye on FDA points out. "That has to change."
It's an opportunity, the blog suggests, for pharma to step up and devise its own plans for assuring the quality and safety of goods imported for use in medicines. There's plenty of time, because Congress will be mulling and debating for months on end. If the industry could beat lawmakers to the punch, they might not only end up with a system they like better, but win some PR points in the process.
- read the Eye on FDA item
ALSO: The heparin saga also seems to have served as a wake-up slap for the FDA, In Vivo notes. Finally, Commissioner Andy von Eschenbach admits that the current problems at agency amount to a "crisis." Report