FDA preps to toughen up

Top among commissioner Margaret Hamburg's six steps towards a strong FDA are a 15-day post-inspection deadline for response by out-of-compliance companies, and then a formal close-out process in which the FDA certifies that the corrections have been made, both by letter and on its website (see previous item, "Hamburg pushes toward ‘strong FDA'").

The remaining steps involve actions to further ensure that violations are taken seriously and actions are quick. The regulator will speed up its process of issuing warning letters by limiting their review to "significant legal issues." As a result, most enforcement letters will enjoy a "more streamlined process. This approach is consistent with the FDA's longstanding historical practice," says Hamburg.

The FDA will also prioritize enforcement via such prompt follow-up as an inspection or investigation.

In addition, regulators will be "prepared to act swiftly and aggressively to protect the public." No more multiple warning letters prior to enforcement action. "If we find that we must move quickly to address significant health concerns or egregious violations," says Hamburg, "we will consider immediate action--even before we have issued a formal warning letter."

- see Hamburg's talk in a 25-minute web cast
- here's the text


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