As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data indicating its actions on the approval of generic medication. However, as noted by NPR in one example consumers and lawmakers pushing for cheaper alternatives to the EpiPen and other high-priced medications are seeking answers about what they describe as a “stubborn” backlog.
FDA’s response
In Kathleen Uhl, MD’s presentation (Director, Office of Generic Drugs at CDER within FDA), she stated the agency is meeting all of its obligation under GDUFA and even going above and beyond its commitments. FDA states it is “building a modern, 21st Century generic drug program,” which is resulting in “significant and sustained increases in communications, actions & approvals.”
According to numbers from FY2016, FDA approved 190 generic drugs with tentative approval to 48. December 2016 was the highest number of approvals and tentative approvals in one month ever for the FDA at 99. CY2015 broke the record for the highest number ever in a year at over 700+.
To continue building the FDA’s operations, Uhl stressed an interested in foundational restructuring, the building of more internal FDA infrastructure, improvement of business processes, hiring and training more staff, a new IT platform, and improved communications. Regarding IT improvements, FDA says it improved communication and increased productivity—a direct result of its improved IT system for the generic drug program. This provides the agency with workload management and review management tools. They have assigned over 130,000 items in this new platform.
The presentation offers a lot of data which is worth reviewing. However, it also stresses there is “no filing backlog” and that filing is currently done in “real time” (31 days). The first step in review is filing. Something acceptable for filing means the application is sufficiently complete to permit substantive review. It does not mean it will be approved.
Industry response
As reported by Stat: “Overall, there’s some improvement,” said Robert Pollock, a former acting deputy director of the FDA Office of Generic Drugs, who now works at Lachman Consultants and advises drug makers on regulatory matters. “But the question is can it be sustained, and will there be progress beyond what we’ve seen.”
Stat explains that generic drug approval is getting more attention due to the national debate over drug costs. Generics now account for 88 percent of all prescriptions written in the United States, according to IMS health. As a result, FDA’s leadership has stressed its work on accelerating generic approvals. And as Stat notes, Adam Fein of Pembroke Consulting, who tracks pharmaceutical distribution, contends the increasing number of approvals is starting to temper the price hikes for generic drugs. But historically, the FDA has been unable to keep up with the pace of marketing applications filed by generic drug makers.
Next GDUFA
Regulatory Focus notes that the median time to market has fallen considerably as GDUFA has progressed. For the fastest 5% of ANDAs approved under GDUFA, the median approval time has gone from about 24 months in FY 2013 to less than 15 months in FY 2015. However, under the next iteration of GDUFA, which will take effect in FY2018, ANDA standard review time will likely be 10 months from submission and priority review would be eight months from submission.
This is compared to the 42- to 44-month average approval time before GDUFA was in place. However, ANDA submissions do continue to outpace approvals and criticism of the median approval times does seem warranted according to Regulatory Focus, when considering that it takes FDA only 10 months to review and approve much more complex new drug submissions.