Margaret Hamburg Outlines Her Plan - Did You Know?

Did You Know?

According to the article, Commissioner Hamburg stated the following in a recent meeting:

"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible."

Her plan to achieve these outlined goals includes the following steps:

  1. Setting clear deadlines for industry response to FDA's inspection findings;
  2. Taking steps to speed up warning letter processes;
  3. Working more effectively and more closely with FDA's partners;
  4. Prioritizing warning letter follow-up and other enforcement related activities;
  5. Dealing with public health risk factors faster and more effectively; and
  6. Motivating companies to perform corrective action by closing warning letters with a new close-out process.

The image of the FDA also seems to be one of Hamburg's main concerns. She is quoted as saying (in the same meeting) that "We must get the word out that the FDA is on the job," and that by following the steps mentioned above, "violative inspection results [will be] taken seriously, that warning letters and enforcement actions [will] occur in a timely manner and that steps [will be] taken to protect consumers in cases where immediate enforcement action is not possible."