GDUFA reduces wait time for generics

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


Currently, according to the Generic Pharmaceutical Association, it takes 31 months for the FDA to review an electronically submitted abbreviated new drug application, which has resulted in a backlog of more than 1,000 applications awaiting FDA approval. Under the recently negotiated Generic Drug User Fee Act, however, the wait time will be reduced by more than two-thirds, to 10 months. The act, for which the FDA released guidelines last month, will provide the agency with nearly $1.5 billion in supplemental funding through user fees and will effectively eliminate the application backlog by the end of fiscal year 2017, according to the GPhA.


In addition, GDUFA will help improve the safety of the country’s drug supply. Currently, according to the GPhA, almost 40% of prescription drugs in the United States are imported, while up to 80% of the active pharmaceutical ingredients in those drugs are sourced abroad. Still, according to the Government Accountability Office, the FDA was able to conduct good manufacturing practice inspections at 11% of the foreign sites in its database, compared with 40% of domestic sites. GDUFA will help increase the number of sites inspected.


“The Generic Drug User Fee Act is a milestone for the generic drug industry and a major win for American healthcare consumers,” GPhA president and CEO Ralph Neas said. “This program, as negotiated, will result in expedited access to low-cost, high-quality generic drugs for Americans, and will further safeguard the quality and accessibility of our nation’s drug supply.”