One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To that end, I have a little database that tracks activity going back through 2009 – looking only at those advisory committees that are listed under the “Drugs” tab on the FDA website.
During the first quarter of 2015, FDA held 8 advisory committee meetings, 6 of which involved new drug or supplemental new drug applications. Of those 6 meetings, the advisory committees recommended approval in 5 of them. Of those 5, FDA went on to approve 4.
By contrast, we are off to a bit of a slower start in the first quarter of 2016. There have been a total of 4 AdComms this quarter, all of which involved new drug considerations. Of those, the Advisory Committees recommended approval in all four of them, including one which was a biosimilar to reference product Remicade and in one that occurred yesterday. With regard to approvals, FDA final decisions as of this writing and the PDUFA date for one of the products has been extended by the agency. As you know, FDA is not bound by the determination of an advisory committee.
As for upcoming meetings, in April there are three meetings scheduled to consider new drugs:
- Obeticholic acid oral tablets for the treatment of primary biliary cirrhosis Gastrointestinal Drugs Advisory Committee – April 7
- Rociletinib Tablets for the treatment of patients with mutant epidermal growth factor receptor non-small cell lung cancer – Oncologic Drugs Advisory Committee Meeting – April 12
- Adapalene for the treatment of acne – an RX to OTC switch – Nonprescription Drugs Advisory Committee – April 15
There will also be a meeting of a few device panels in April as well as the Pediatric Advisory Committee – All meetings are listed here.
At the conclusion of this quarter in a few days, we’ll review FDA press releases compared to last year at this time, including approval announcements.