A new user fee is bringing in the money to help speed up generic drug applications the Food and Drug Administration commissioner told attendees of the Generic Pharmaceutical Manufacturers Association’s (GPhA) annual meeting last week.
“In the few months since the program has been up and running, we have collected almost $125 million in fiscal year 2013 user fees that will help us begin recruiting and training additional staff we need to achieve the program’s performance goals,” said FDA Commissioner Margaret Hamburg, MD, during a live webcast of her Feb. 22 presentation to GPhA’s membership.
As a result of the Generic Drug User Fee Amendments (GDUFA) passed last summer, the FDA has already seen significant reductions in the backlog of generic drug applications awaiting decisions said Hamburg.
Before GDUFA, FDA was drowning in generic drug applications of almost 1,000 a year, pushing the backlog of abbreviated new drug applications above 2,500, and stretching the median time for generic drug approvals to 31 months, she said. Less than 1 percent of unprocessed abbreviated new drug applications have outstanding fees, she added.
GDUFA gave FDA the authority to charge user fees, which gives the agency resources so it can hire more reviewers to speed up determinations.
GDUFA was designed to level the field for foreign and domestic drug makers to meet the same manufacturing quality system standards; to accelerate the availability of more affordable high quality generics drugs; and to enhance FDA’s ability to identify and track registration of all contributors involved in each drug product sold in the United States.
The disparity in the degree of oversight experienced by domestic versus foreign facilities created an uneven playing field, but the user fee program will change that, Hamburg told her audience.
“Within five years, we will be able to conduct biennial inspections for both domestic and foreign facilities, allowing us to identify any noncompliant players in the drug supply chain – wherever they are based – so we can focus on the generic drug industry worldwide,” Hamburg said.
Another feature of the new program is requiring manufacturers to self-identify so the agency can build a new facilities database, which now has a list of 2,000 facilities involved in supplying generic drug products.
The generic drug industry is playing an increasingly larger and transformative role in the nation’s healthcare system, Hamburg said. Generic drug companies now provide 85 percent of all of the prescriptions filled in the United States, which over the last decade has contributed an estimated $1 trillion in savings to the healthcare system, she said.
Given the size and impact of the generics industry, there is a need for continued focus on quality along every facet of the supply chain, including facilities, she said.
“As we see increased numbers of marketing applications for new innovator and generic drugs, including more complex dosage forms and delivery systems, the need for greater focus on quality is all the more imperative,” she said.