FDA: 2015 saw record generics approvals, OGD on track with GDUFA goals

SILVER SPRING, Md. — The year 2015 saw the highest number of approvals and tentative approvals of generic drugs ever at the Food and Drug Administration according to a new report released by the Office of Generic Drugs. 

 

The report notes that in 2015, the OGD granted 580 approvals and 146 tentative approvals, including 99 in December alone – the largest number of drug approvals given out in a single month. The report also highlights the changes that the Office of Generic Drugs has seen since the Generic Drug User Fee Amendments passed in 2012, giving the FDA additional funding to review and approve generic drugs. 

 

The OGD has currently met or exceeded measurable performance goals outlined in the GDUFA commitment letter, completing first actions on 84% of backlogged abbreviated new drug applications (those filed before Oct. 1, 2012) and 88% of backlogged prior approval supplements. 

 

“We are confident in OGD’s ability to meet our GDUFA goals,” OGD director Dr. Kathleen Uhl said in the report. “There is incredible momentum. We are proud of our accomplishments so far, and we in OGD and the other offices involved in generic drug review activities are enthusiastic about GDUFA Year 4.”

 

Since GDUFA passed, the OGD has worked to streamline its workflows to decrease approval time and it launched the an informatics platform that supports review, approval and management of ANDAs, supplemental ANDAs, controlled correspondence pertaining to generic drug development, facility inspections and user fee checks.  

 

The organization has also sought to improve its relations with the industry and stakeholders, holding a forum on regulatory education for the industry, offering a webinar about controlled correspondence for generic drug development and shared information about patents and exclusivity through its newsletter. 

 

As part of its efforts to connect with stakeholders, the OGD will hold a public meeting on May 20 to garner feedback about its regulatory initiatives and chart a path forwards. 

 

“Despite our progress, we have a lot more work to do, but we want to do this collaboratively,” Uhl said. “Achieving ambitious goals that work for the public health requires broad input from the public, including industry, the research community, lawmakers and other stakeholders. … “With our ongoing efforts — and strong public input — we are confident that 2016 and beyond will be as successful as 2015.”