The current pace of generic approvals in the U.S. could lead to a record year.
FDA has taken specific steps to increase the rate of approvals of generic drugs, and the moves have led to real results. With just over 10 months in the 2017 Fiscal Year completed, FDA has approved 633 generic drugs – slightly shy of the 651 total approvals in the Fiscal Year 2016. It appears as though the agency has a real chance of reaching a record-level of generic drug – or abbreviated new drug application (ANDA) – approvals.
What has made such an impact? Several actions by FDA are leading to the accelerated approvals. In late June 2017, FDA prioritized the review of ANDAs, for which there are fewer than three ANDAs approved for the reference listed drug and also released a list of with limited or no competition. These moves came after the release of an amendment to the Senate user fee reauthorization bill that included the prioritization of generic approvals. In March 2017, FDA had said it would prioritize ANDAs with only one competitor. There are several other generics that can receive priority reviews, including those that target drug shortages, are related to public health emergencies, etc.
FDA Commissioner Scott Gottlieb also stated that “No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require.” He has pushed for more generic approvals to reduce costs and increased the staff at the Office of Generic Drugs (OGD), which is also looking to identify new ways to apply the Hatch-Waxman act to increase competition. A working group will evaluate existing policies and consider possible new legislative approaches to balancing innovation and access to lower-cost medicines.
The Generic Drug User Fee Amendments (GDUFA) also established faster review timelines for generics. The latest version of GDUFA goes into effect in October and includes mechanisms for speeding generic approvals for branded drugs with little competition.
Still to be addressed, according to both industry and FDA, is the need to reduce the number of review cycles and the time it takes to approve complex generics.
