Last year, heparin. This year, salmonella (again, but on a much larger scale), and news of a plant that was never inspected.
President Obama plans to launch a full-scale study of what's gone wrong. But there have already been many studies that seem to suggest the same thing....that FDA can't oversee two vast global industries by itself, and especially not using the approaches of the past. Drugs, including generics and the wild west of supplements and nutraceuticals would be more than enough for any government Agency. As the industry moves to more personalized therapies, there will be an even greater demand on reviewer and inspector time.
Why not separate food regulation and have that done by DoA?
Whatever happens, one hopes that political pressures won't derail the progress that has been made within FDA, in adopting more modern, risk-based approachs to regulation.
Consultant John Avellanet makes some great suggestions in the Biotech Blog. Click here to read.
AMS
