FDA is on its way of getting a boost to its 2009 budget for strengthening its drug-import safety program. Earlier this week, HHS Secretary Leavitt asked Congress for an additional $100 million to improve international safety points, from preapproval testing to postapproval surveillance.
In Leavitt’s words, the agency is “rolling the borders back and seeking to build safety and quality into products at every step of the way before they reach American consumers.” Sound familiar? In effect, the agency is demonstrating the importance (and of course, associated cost) of implementing quality by design.
Is this enough? The $100 million increase (additional funds are going to food safety and scientific upgrades) would be helpful, but it is far short of the $225 million FDA officials said it needed to inspect the 3300 drug manufacturers overseas. I wonder also whether any of the increase will go toward training foreign manufacturers on GMP and quality by design systems. It seems like it would make the investment worthwhile. And will the funding for overseas inspections still be available when the dust from the heparin crisis has settled and the incident has long been “forgotten” in the public eye so that the “perceived risk” is not as high?