Senate Scrutinizes Generic Drug Approval Backlog

FEBRUARY 03, 2016
Allison Gilchrist, Associate Editor

A US Senate committee recently held a hearing to investigate the culprits behind the growing backlog of generic drug applications at the FDA.


The Generic Drug User Fee Amendments (GDUFA), which took effect in 2012, were designed to expedite the availability of low-cost, safe generic drug products for patients while lowering costs for the health care industry as a whole.


GDUFA requires generic industry stakeholders to pay user fees to supplement the costs associated with reviewing generic drug applications and inspecting facilities faster. These fees are intended to ultimately help applicants market their drugs earlier.


However, members of the US Senate Committee on Health, Education, Labor, and Pensions recently said the FDA is still too slow to approve generic drugs, despite Congress’ $1 billion investment in the initiative.


“I understand that the FDA has met most of the goals laid out in the agreement for industry user fees for regulatory actions, hiring staff, and increasing inspections, but I look forward to hearing whether these metrics are the most appropriate, given that I continue to hear that generic drug approval is too slow from manufacturers and patients,” said Chairman Lamar Alexander (R-Tennessee) in his opening remarks at the “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs” hearing.


Presently, the FDA’s backlog contains more than 3800 generic drug applications, while average approval wait times have stretched from 31 months in fiscal year 2012 to 42 months in fiscal year 2014.


The sole witness at the hearing was Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER). In her testimony, Dr. Woodcock touted the overall success of the generic drug program.


“The generic drug industry has grown from modest beginnings into a major force in health care,” she stated. “…Generic drugs now account for 88% of prescriptions dispensed in the United States and have saved the nation’s health system $1.68 trillion from 2005 to 2014.”


Dr. Woodcock also noted that of the 2866 generic drug applications that were in the approval backlog as of October 2012, the FDA has completed “first action” on 84% of them. The agency has also committed to completing first action for 90% of backlogged applications before the legislative authority for GDUFA expires at the end of September 2017.


Despite these figures, ranking committee member Sen. Patty Murray (D-Washington) said some in government are concerned that the remaining backlog of generic drug applications at the FDA are “part of the reason patients and families are experiencing high drug costs.”


Specifically, Sen. Murray said many believe that slower generic drug approval times generally mean less competition, allowing the company selling the innovator drug to price it without any downward pressure from market forces.


However, Dr. Woodcock explained that when an application is for the first generic competitor to the innovator drug, the agency expedites it.


“They get the fast track,” she asserted.


In a press release, the Generic Pharmaceutical Association (GPhA) noted that during the hearing, Dr. Woodcock testified that the FDA expressed concerns regarding the quality of generic drug applications.


GPhA wrote that the association “supports the submission of complete [applications] to promote an efficient FDA review process, [but] there must be a clear and objective definition and criteria for [application] ‘quality’ in order to evaluate the scope and nature of the problem.”


The US Senate Special Committee on Aging also intends to consider the FDA’s role in the generic drug approval process, in addition to distribution protocols and off-label use regulations.



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