GDUFA tackles backlog of drug approval applications, FDA hires more staff

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

When Congress approved a reauthorization of the Prescription Drug User Fee Act that included the Generic Drug User Fee Amendments last year, that backlog included about 2,500 applications. But thanks to GDUFA, the agency has managed to clear muchof it.

As of last month, more than 40% of the backlog applications had been reviewed, according to the FDA, which had collected more than $255 million in user fees to finance the program. Also last month, the agency announced that it exceeded its staff-hiring goals, having hired 234 new workers, three more than the 231 planned. In total, it hopes to hire 921 in a three-year push, including 461 people during fiscal year 2014.

“I am extremely happy with this accomplishment,” Center for Drug Evaluation and Research director Janet Woodcock wrote in a memo to FDA staffers. “As hiring continues through the end of this fiscal year, planning has already begun for next fiscal year.”

The Generic Pharmaceutical Association greeted the news with excitement. “Making these hiring decisions is an important step to achieve the goal of [the Generic Drug User Fee Amendments] and address the delays that reduce Americans’ access to affordable medicines,” GPhA president and CEO Ralph Neas said. “The FDA has a critical task at hand: reducing the backlog in applications for new generic medicines and speeding the average [abbreviated new drug application] approval time.”

For fiscal year 2014, the agency hopes to conduct post-market evaluation of generic drugs that will include research into surveillance and monitoring methods for them while gauging patients’ perceptions of generic drug quality and effectiveness. Other research will focus on the equivalence between generic inhaled, topical, dermatological, nasal, ophthalmic and other generic drugs and their branded counterparts, as well as research on abuse-deterrent systems for drugs prone to abuse, which would include opioid painkillers.

The FDA also is increasing generic drug user fees for the fiscal year. For example, the fee for filing an abbreviated new drug application, or ANDA, will be $63,860, compared with $51,520 for fiscal year 2013, a 24% increase.