The FDA’s New “Get Tough” Enforcement Policies

January 15, 2010

On August 6, 2009, FDA Commissioner Dr. Margaret Hamburg publicly announced the FDA’s new enforcement strategy. This strategy involves 6 new policies that went into effect on September 15, 2009 – what are the policies, and what do they mean to you?

1. The FDA will set post-inspection deadlines. Firms will generally have no more than 15 working days in which to respond to serious violations before the FDA moves ahead with a warning letter or enforcement action.

Impact: it is important to note that there is no regulatory requirement to respond to 483 observations. Therefore, a warning letter will not be issued just because you didn’t respond in a timely manner, or respond at all. However, if the FDA feels that the violations are serious and want to issue a warning letter, they will only review your responses to defend yourself (state your case) if they are sent within 15 days.

2. The FDA will take responsible steps to speed the issuance of warning letters. FDA’s Chief Counsel will limit warning letter review to significant legal issues, therefore allowing most enforcement letters to move forward through a more streamlined process.

Impact: since you have only 15 days to state your case through responses as stated in policy #1 above, the speed at which the FDA operates internally has very little impact on the actual outcome other than timing. Historically, the longer the FDA took, the more opportunity you had to send in multiple responses and proof that you had implemented what you said you were going to implement. However, once the FDA heads down the path of warning letter, there is very little you can do now to stop the train.

3. The FDA will seek to work more closely with our regulatory partners to develop effective risk control and enforcement strategies. This action is mainly focused on the food industry, where local, state, and international offices have more authority than the FDA to take action quickly.

Impact: hopefully greater safety for us as consumers once suspect food is out in the market.

4. The FDA will prioritize enforcement follow-up. After a warning letter or product recall, the FDA will make it a priority to follow-up with appropriate action.

Impact:The FDA will be coming in sooner to verify that you have done what you said you were going to do, and that your actions were effective. There is less time to implement a corrective action and see the benefit of that action. Corrective actions need to be thorough.

5. The FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will consider immediate action without the issuance of a formal warning letter when necessary.

Impact: Not necessarily new, just greater emphasis and perhaps greater empowerment to the Districts to act when they feel it is necessary. For example, TEVA Animal Health received a consent decree July 2009 without a warning letter being issued first.

6. The FDA is developing a formal warning letter “close-out” process. If the FDA can verify the effectiveness of corrective actions (typically through reinspection), then a close-out letter will be issued to signify closure of the warning letter issues.

Impact: clear indication to industry and investors that the FDA truly is satisfied with corrective actions and that warning letter issues are resolved. The problem might be if there are resource constraints for the FDA getting back to your facility to verify, then it might send the wrong message to the rest of the industry.

The best line of defense is to have excellent quality oversight now to ensure that the systems you have in place are compliant, functional, and effective. Then you won’t have to worry about getting a warning letter in the first place. Easier said than done, but more critical now than ever.

 

 

Tags: FDA , FDA responses , FDA warning letters , FDA enforcement action

Add comment