We Need More Overseas Inspections

Oct 02, 2007


Angie Drakulich
Offshore contracting is nothing new for the pharmaceutical industry. Neither is importing active ingredients, or prescription drugs, for that matter. But the authorities are having trouble keeping up with these growing international trends.

In August, Senator Chuck Grassley (R-IA) requested a briefing with the US Food and Drug Administration to discuss concerns about the agency's oversight abroad. He referenced former FDA associate commissioner William Hubbard's recent comments to the Washington Post that FDA's foreign inspections of pharmaceutical manufacturing plants are "dire and deteriorating" and called into question the agency's protocols and strategies. Indeed, the number of overseas inspections conducted by FDA is subpar (only 500 of the 2,700 inspections carried out in 2006 were abroad).

The ongoing concern over made-in-China products has not helped matters. Congress and Americans are paying much more attention now to what's coming across our borders and how things are regulated—as they should be. Being aware of imported products—and being reassured of their safety—is important, but if we are so concerned, blaming FDA won't do us any good. Instead, we need to call for more FDA support.

Take a look, for example, at the President's FY2008 budget for FDA programs. It provides only a 5.3% increase ($105.8 million) from FY2007, for a total FDA budget of $2.1 billion, despite the agency's ever-increasing responsibilities due to globalization. And sadly, there is barely a mention of international inspections in the agency's budget summary of goals and initiatives for the year ahead.

It's clear that we need a more efficient, multilateral regulatory system—even FDA officials will admit this when asked, which is why harmonization is becoming more and more popular by the minute. But to achieve the global capacity needed, everyone must be willing to contribute and support those tasked with the job.











Angie Drakulich is the managing editor of Pharmaceutical Technology,