No more stalling, your FDA commissioner says. Dr. Margaret Hamburg vowed yesterday to crack the FDA whip more quickly and aggressively, with procedural changes designed to speed up safety enforcement. No more long, drawn-out internal debate. No more long-drawn out negotiations with companies. It's action time.
Hamburg is taking some common-sense steps that, frankly, beg the question why they haven't been done before. For instance: Clear deadlines for companies' response to FDA inspection reports, and a follow-up process for warning letters to make sure problems have been corrected.
And then there's a planned speed-up in the warning letter process; currently, the agency's lawyers review every letter, and in future they'll only look at those that "present significant legal issues," according to an FDA statement. And believe it or not, the FDA may even act before a warning letter is issued. In case of big public-health risks or major violations, that is. We're bewildered that the agency was waiting on the mail in those cases before.
"In some cases, serious violations have gone unaddressed for far too long," Hamburg admitted during a speech to the Food and Drug Law Institute, saying that enforcement processes "can be too long and arduous when the public's health is in jeopardy." And she added, "We must get the word out that the FDA is on the job."
- read the FDA release
- see the news in the Washington Post