By: Anthony Warchut, Vice President Technical, PAREXEL® Consulting
Translation; Why your 15 day response letter just became even more important.
On August 18, 2017, the Food and Drug Administration Reauthorization Act (FDARA) was signed into law, which included the Generic Drug User Fee Act II (GDUFA II). GUDFA II requires that FDA classify inspections within 90 days of the close out of the inspection. FDA committed to implement this 90-day classification requirement by October of 2018. However, at the ISPE/FDA/PQRI conference in June of 2017, the Director of the Office of Manufacturing and Quality (OMQ) at the time, Tom Cosgrove, stated that FDA’s goal was that the 90-day classification requirement would be implemented sooner and would not be limited to generic drugs.
This change will increase the importance of your 15-day response letter to the FDA, because there will be less time for the agency to make their final inspection classification decision after the end of an inspection. Although FDA has committed to reading post 15-day response submissions (also confirmed by Mr. Cosgrove at the same conference), companies have gotten used to providing more complete information in subsequent updates to the initial response letter. However, in the future, for companies that may expect an Official Action Indicated (OAI) classification, it will be even more important to provide a high-quality and robust 15-day response letter. Failure to do so will increase the probability that FDA will classify the inspection as OAI, and such classification could mean that there will be a Warning Letter, potential for an Import alert for foreign manufacturers or some other type of enforcement action taken by the agency. The quality of the 15-day response letter will be directly proportional to the increased probability that the inspection will be classified as VAI rather than OAI.
Don’t wait until it’s too late and you end up with an OAI classification. Don’t go it alone with limited experience of what the FDA is expecting in a good response letter. PAREXEL can offer valuable advice on how to avoid the pitfalls of a poorly written response letter and what needs to be in a well-written 15-day response letter. For more on this topic, read the full article on what deficiencies FDA has observed in response letters and how PAREXEL® Consulting can assist your company in creating a well-written 15-day response letter in the future paradigm of FDA’s 90-day inspection classification.