FDA prepared to act more aggressively

In her speech, Dr Margaret Hamburg pointed out that the FDA wants to ensure the protection of the USA's public health by means of a rapid, effective and aggressive enforcement of laws and regulations.

Besides she said that in the past years many of FDA's enforcement actions were hampered by unreasonable delays and that in some cases even grave deficiencies remained unaddressed for too long. The Agency must be vigilant, quick, strategic and visible.

In order to reach this, Dr Hamburg mentioned six steps marking the beginning of an FDA approach that focuses more on effectiveness and timeliness:

  • Introduction of a post-inspection deadline: The FDA intends to set a clear time span of 15 days within which a firm has to respond to inspection findings. After the deadline, a warning letter will be issued or even more far-reaching measures will be taken.
  • Acceleration of the warning-letter process through a streamlined internal review of warning letters.
  • Better co-operation with other regulatory authorities: Especially with regard to food safety matters, other authorities can act more swiftly than the FDA. The co-operation with them is meant to be improved.
  • Prioritisation of follow-up activities by the FDA: The follow-up on corrective measures after warning letters or major product recalls will be assigned a higher priority.
  • Taking immediate action: In order to ensure the protection of the USA's public health, measures may be taken even before a warning letter is formally issued.
  • Developing a warning letter "close-out" process: In order to raise the motivation for implementing all necessary corrective action, firms that have fulfilled all requirements defined in a warning letter will be listed on the FDA website.

The complete text of the speech held by Commissioner Dr Margaret Hamburg as well as the webcast of the speech can be found on the FDA website.

Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)

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