FDA's First 90-Day Letters To Deliver Inspection Outcomes After Jan. 1

Tom Cosgrove spoke at the Food and Drug Law Institute's enforcement conference and is quoted by The Pink Sheet in an article regarding FDA's anticipated release of the first 90-day letters. According to Cosgrove, "You will be getting these classifications in 90 days and final means final. What does that mean for people working on these classifications? That means they will be working quickly. I mean they will be cutting to the most important part of the inspection and making a disciplined decision in a short amount of time." He adds that the accelerated timeline "raises the possibility that there are going to be more OAIs and more enforcement actions."

Cosgrove said that the program is a vast improvement over the former program in that it specifies much-needed goals for making regulatory decisions following inspections. He noted that the 90-day classification letter gives manufacturers, particularly generic manufacturers, a clear idea of the compliance status of their contract manufacturing partners. "In the generic industry…there is more use of CMOs and more complex supply chains and there are sponsors with relatively far flung manufacturing chains and not the kind of knowledge of their contract manufacturers. So they did not know the status of the manufacturing facilities."