The US Food and Drug Administration (FDA) recently released its five-year financial plans to communicate the anticipated financial positions of the Biosimilar User Fee Amendments of 2017
(BsUFA II), the Generic Drug User Fee Amendments of 2017
(GDUFA II) and the Prescription Drug User Fee Amendments of 2017
(PDUFA VI) programs over the current five-year authorization period.
The user fee programs were reauthorized in August 2017
, setting the path for what pharmaceutical, biotech, medical device and other companies will pay the agency for timely reviews of their products.
The sixth reauthorization of the PDUFA program makes it a relatively mature one (in comparison to the other user fee programs), though FDA notes that its workload has been steadily increasing.
For instance, in 2017, the agency says it received 57 new molecular entity (NME) NDAs and original BLAs (10% increase), 106 non-NME NDAs (26% increase) and 243 efficacy supplements (37% increase). In addition, the agency says that in the previous five years of PDUFA V, its formal meeting workload increased by 50%.
And these increases are expected to continue under PDUFA VI, which stipulates that the agency expand its patient-focused drug development program, improve its management of combination products, create new programs on complex innovative trial designs
and model-informed drug development
, and explore the use of real world evidence
for safety and efficacy determinations.
As the number of abbreviated new drug applications (ANDAs) for generic drugs continues to increase, GDUFA II will set FDA up to deal with the volume, which has been at record highs in recent years
, as well as the review timeframes, which FDA characterized as “much more aggressive than in GDUFA I.”
The agency notes, “A great deal of manufacturing has moved overseas in the past few years which has resulted in the need for FDA to conduct more foreign inspections which tend to be more expensive.”
Although those expenses are offset by the foreign fee differential that overseas manufacturing facilities pay, FDA notes, “Other unpredictable trends in the market could likewise impact FDA’s resource consumption.”
Meanwhile, the agency will have to build up a new program for complex generic drugs, with additional support to applicants in preparing ANDAs, while CDER’s Office of Pharmaceutical Quality (OPQ) conducts research and testing on complex generics to identify scientific and technical review challenges.
“There are also other enhancements needed such as OPQ’s development of the Knowledge-Aided Assessment & Structured Application (KASA) platform which will enhance lifecycle management of drug products,” FDA says.
At the beginning of BsUFA I, the regulatory pathway for biosimilars was relatively new (the Biologics Price Competition and Innovation Act was signed into law in 2010) so much of FDA’s work was focused on providing development-stage advice to sponsors.
“During BsUFA I, FDA received fewer original biosimilar biological product application submissions than the Agency had initially expected to receive, which resulted in the collection of relatively more BPD fees than expected and fewer application, establishment, and product fees,” the agency says.
FDA added that it expects many of the development programs started in BsUFA I will convert to original submissions early in BsUFA II, which would contribute to an increase in application review work relative to BsUFA I. To prepare for such an influx of review work, FDA says it has committed to hire 15 full-time employees in FY 2018.
User Fee Five-Year Financial Plans