The US Food and Drug Administration (“FDA”) recently published its quarterly Real Time Report on new drug application (“NDA”) and biologics license application (“BLA”) filings for FY 2019. The report shows that numerous NDAs and BLAs were filed in the first quarter (“Q1”) of FY 2019, with 53 and 4 filings, respectively. These numbers were higher than any quarter of FY 2018, with Q1 being the highest and having 46 NDA and 7 BLA filings.
These Real Time Reports are mandated by the FDA Reauthorization Act of 2017 (“FDARA”), which amends the Food, Drug and Cosmetic Act to extend user fee programs which expire every five years. In addition to the user fee extension, FDARA requires the FDA to publish these real time reports containing metrics of NDA and BLA filings and approvals, as well as a listing of the number and titles of draft and final guidance documents related to the NDA and BLA review processes, and a listing of the number and titles of public meetings held on these same topics.
While the report shows an increase in filings in Q1 FY 2019, the number of approvals have actually dropped compared to Q1 FY 2018, with 43 NDA approvals in Q1 FY 2018, but only 37 in Q1 FY 2019. Similarly, there were 8 BLA approvals in Q1 FY 2018, but only 7 in Q1 FY 2019.
This filing and approval data can be used to inform policy discussions about balancing the thoroughness of review with the need to speed new drugs and biologics to market, particularly in cases of unmet medical need. The FDA already has a number of programs in place to make drugs available as rapidly as possible, including Priority Review, Breakthrough Therapy, Accelerated Approval and Fast Track.
In addition, the FDA committed to certain performance goals in its Prescription Drug User Fee Act (“PDUFA”) commitment letter, which was part of the negotiation with the biopharmaceutical industry for reauthorization of user fees. For instance, the FDA committed to review and act on 90% of standard new molecular entity (“NME”) and non-NME NDAs, and original BLAs within 10 months of the 60-day filing date. The publication of this filing and approval data will provide the FDA, biopharmaceutical industry, patient groups and other stakeholders with consistent information about the FDA’s performance, and provide insight on how to improve the approval process going forward.
The Biotechnology Innovation Organization (“BIO”), an industry group that represents the biotechnology industry, applauded FDARA, saying in a statement that it “takes important steps to advance patient involvement in drug development.” It should be noted, however, that there do not seem to be any penalties for the FDA if it fails to comply with its review commitments, so it remains to be seen how much these filing and approval reports will impact the process.