By Kurt R. Karst –
Do you have an ANDA prior approval supplement pending at FDA? How long has it been pending – 6 months? One year? 18 months? Well it might still some time until there is any action on it. Over the past few weeks we have received sporadic reports that FDA’s Office of Generic Drugs (“OGD”) has quietly placed a hold on ANDA prior approval supplement reviews and approval actions until further notice to focus instead on original ANDA submissions (and minor amendments).
Although the details of the directive are still a bit sketchy, from what we understand, it is not a per se suspension. OGD will review ANDA supplements if there is a compelling reason, such as supplements that might ordinarily qualify for expedited review – i.e., “supplements which would accomplish a public health need, eliminate an extraordinary hardship on the applicant, or accomplish a bona fide Agency goal” (MaPP 5240.1). But that is the exception to the directive. We also understand that although OGD hopes the directive will be short-lived it could remain in effect until OGD has made some headway in addressing the original ANDA backlog. As we previously reported, and according to FDA-Track, there is a backlog of more than 2,000 original applications – 2,136 as of June 2010 (approximately 1,600 of which have been pending for more than 180 days). And the backlog continues to grow. So OGD has apparently decided to let the ANDA prior approval supplement queue grow (which may account for 50% of the total supplement backlog of about 3,900) in an effort to shorten the original ANDA queue.
Word of the ANDA supplement review directive has come out just as the debate over generic drug user fees has been heating up. On Friday (September 17th), FDA will hold a public meeting to discuss and solicit from industry what a generic drug user fee system might look like. There are several significant issues to be discussed, including how to handle the ANDA backlog and what the review goals should be. And, of course, legislation needs to be enacted. Industry will certainly not be happy to learn that supplement reviews have been stalled for the time being, even though there is a renewed effort to use “scarce agency resources” to tackle the original ANDA queue, for which OGD has been criticized. The supplement directive could help drive FDA and stakeholders to come to a quicker consensus on generic drug user fees.