Good news, with caveats: New enforcement numbers out from FDA and a new searchable inspection database suggest the agency has ramped up its crackdown on unsafe and substandard food and drugs.
The number of warning letters, injunctions and seizures, the agency’s three main enforcement actions, all rose in 2010: warning letters by 42% over 2009, injunctions by 55%, and product seizures by 67% in the same period. (Source: FDA Webview)
Meanwhile, the agency is moving ahead with its transparency project, unveiling a searchable database of inspections which the public can use to view inspection dates, info, and actions taken in both foreign and domestic inspections. Search entries returned don’t link to associated warning letters, which would be useful in linking inspectors’ actions with the problems they found. But a quick tour through the database suggests that the functionality is straightforward, and that here the agency has taken an important step to increase transparency around its enforcement activities, even as those activities have accelerated. It should be commended for that.
So what about these caveats? Well, enforcement volume doesn’t necessarily correlate with things that need enforcing, especially considering the wide swaths of ground FDA is working to cover in the area of foreign inspections (a recent GAO report suggests that foreign drug plants get inspected an average of once every 9 years). But as we’ve observed here before, product recalls continue to trend up on both the food and drug side. And the 2010 numbers are no exception. Being company-generated, those aren’t enforcement actions, per se, and can stand as a rough measuring stick that suggesting the number of safety and quality manufacturing problems out there is still on the rise.
The agency’s move to tighten oversight and sanctions is critical, timely, and sorely needed. Congress should take note of the agency’s progress and the scope of enforcement work, and make sure FDA has the resources and additional enforcement authorities it’s been seeking to keep pace with the safety and quality problems here and abroad.
–Kate Petersen, PostScript blogger