New FDA Commissioner – New Edits on dealing with the Industry – But, is New always good for the Industry?

Recently at the FDLI meeting, the new FDA Commissioner, Margaret Hamburg, M.D., was asked to speak to the audience of FDA industry representatives, on the subject of "Effective Enforcement and Benefits to Public Health".

The new FDA Commissioner came with some major “new” initiatives that the FDA intends to impose concerning FDA enforcement practices.

Below are the six changes that she mentions that can be expected in the FDA enforcement practices. These new practices are being implemented to Protect the American public. As you will see, these initiatives will put a lot of pressure on the FDA regulated industries. Therefore, it is critically important to assure the industry fully understands the FDA objectives and its expectations for industry cGMP compliance. It would appear that making a miscalculation in this area could result in the issuance of a Warning Letter, expedited FDA follow up and if problems still exist, additional swift regulatory actions. How this will be enforced Region to Region will be interesting to observe as the FDA moves to a high octane regulatory agency looking to “enforce” the regulations fast and furious.

The six new initiatives are:

“First, the FDA will set post-inspection deadlines. When the FDA finds that a firm is significantly out of compliance, we expect a prompt response to our findings. Once the FDA provides inspection findings identifying a serious problem, the firm will generally have no more than fifteen working days in which to respond before the FDA moves ahead with a warning letter or enforcement action. This will help FDA issue warning letters on a timely basis and facilitate prompt corrective action.

Second, the FDA will take responsible steps to speed the issuance of warning letters. I have approved a new policy brought forward by the FDA’s Chief Counsel to limit warning letter review to significant legal issues. As a result, most enforcement letters will be able to move forward through a more streamlined process. This approach is consistent with the FDA’s longstanding historical practice.

Third, the FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies. In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA. When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses.

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action, such as an inspection or investigation to assess whether or not a company has made required changes in its practices.

Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. 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.

A sixth new practice is a little different from the others. It relates to our response to firms after they have made necessary corrections.

At my direction, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, we will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. To keep the public informed, we will indicate on our website when a firm has received a “close-out” letter.

Not every type of warning letter will be eligible for a “close-out” letter. But for ongoing violations, it could play an important motivating role in spurring corrective action”.

It would be nice if the FDA act on this point with the same urgency they plan to handle the other 5 items and makes sending out a “close-out” letter a top Agency priority as well.

If you have been dealing with the FDA for a long period of time, you would have seen these types initiatives every 10 years or so. So things are not really changing and in fact, could be seen as going back to where the Agency stood previously on many of these initiatives. Making sure that the FDA can be understood by the industry, that there are no moving targets concerning compliance issues, and Region to Region uniformity in how these new enforcement initiatives are implemented should be the FDA’s goals.

If you review the content of mdi’s website over the past few years, one of our predictions was a more stringent FDA. This prediction was based on the new Congressional make up over the past 3 years. A Democratic control of the FDA oversight will assure that the FDA will being looking at the industry with a much stricter regulatory stance. This prediction is now coming through. Be prepared to see an FDA that will be much harder to deal with. Understanding the FDA’s enforcement goals and developing corresponding regulatory strategic planning will be critical to your survival.

For more information on this article, please email mdi at info@mdiconsultants.com and reference FDA Commissioner