On January 6, 2014, FLH Partner Brian J. Malkin was quoted in an article by Derrick Gingery in The Pink Sheet entitled “Generic Drugs 2014: OGD Creates Internal Review Goals, May Make OND-Inspired Changes”.
Gingery’s article focused on FDA’s Office of Generic Drugs (“OGD”) taking steps to meet review deadlines that will be imposed by the Generic Drug User Fee Act (“GDUFA”), and enacted by the Food and Drug Administration Safety and Innovation Act (“FDASIA”) of 2012. For example, sixty percent of all applications accepted for filing in fiscal year 2015 must be reviewed within 15 months, which is included in a GDUFA commitment letter. According to the article, as of December 1, 2013, OGD’s project managers started setting internal goals to help reviewers get used to a review clock–a new concept for OGD but something that has been around since the Prescription Drug User Fee Act (“PDUFA”) first implemented in the 1990s for FDA’s Office of New Drugs (“OND”). Acting OGD Director Kathleen Uhl, M.D. (“Cook”) commented there, “We need to have all the reviewers practice the review to a goal date and then we need to monitor what’s our predictability of meeting those goal dates.” Uhl also told Gingery that the “primary purpose” of the goal dates was to help OGD determine the time it will take to complete various parts of the abbreviated new drug application (“ANDA”) reviews and would not be shared with sponsors.
Malkin was asked to comment on the internal goals, which appeared in the article as follows:
Attorney Brian Malkin, of Frommer, Lawrence and Haug LLP, agreed that the internal goals likely would not be helpful to sponsors.
“They’re not going to be able to react to FDA’s deadlines unless FDA shares additional information with them, except perhaps to set some of their own timetables for what FDA may be doing on their end,” Malkin said in an interview.
Malkin said the aim appears to be finding areas where the process can become more efficient.
“It’s tied to FDA’s realistic expectations of what they can do to meet their timeframes, but also … it may not be exactly what industry thought they were getting,” he said. “The concept would suggest shorter review times, but we’ll have to see.”