The Food and Drug Administration is going to toughen some of its enforcement efforts, according to BNA news service ($). In two recent speeches senior FDA officials outlined their plans for increasing inspections and their expectations of the firms FDA regulates.

FDA Commissioner Margaret Hamburg told the Food and Drug Law Institute that the agency will be less lenient when issuing warning letters to companies whose products pose a risk to consumers. Hamburg said that FDA will expect faster responses to warning letters and, in the case of severe risks, will bypass the use of warning letters and take swift action to address the risk. From Hamburg’s prepared remarks:

The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action. If we find that we must move quickly to address significant health concerns or egregious violations, we will consider immediate action – even before we have issued a formal warning letter. (Emphasis in original.) 

FDA is also going to increase the number of inspections it conducts at medical product facilities, according to Mark Roh, the head of FDA’s Pacific division. BNA reports:

Over the next two years, for example, the number of inspections related to domestic drugs for humans will rise from 1,224 in 2008 to a target of 1,299 in 2010 and 2011. The number of examinations for human drug imports will rise from 2,863 in FY08 to a targeted 6,197 each in FY10 and FY11.

The number of foreign inspections is expected to increase 100 percent in three years while domestic devices are expected to rise from 1,705 in FY08 to 1,730 each in FY10 and FY11, he said. 

This is not the first time Hamburg or her deputies have pledged to get tough on companies peddling potentially dangerous products. While I’m sure FDA will continue to cooperate with the industries it regulates, Hamburg’s rhetoric – and the action that follows – is necessary if she’s going to turn around the agency’s sagging reputation.