Regulatory Focus™ > News Articles > FDA to Generic Drug Industry: User Fee Program Leading to Significant Improvements

FDA to Generic Drug Industry: User Fee Program Leading to Significant Improvements

Posted 04 February 2014 | By Alexander Gaffney, RAC

Perhaps no industry regulated by the US Food and Drug Administration (FDA) is undergoing as big a change in the way it is regulated right now as the generic drug industry.


Under the terms of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the generic drug industry must now contribute to FDA's operational budget through user fees. Those fees are paid every time a company submits an abbreviated new drug application, a drug master file, a facility registration, as well as a large number of other activities.

As with other user fee programs for pharmaceuticals and medical devices, the appeal of the user fee program, known as the Generic Drug User Fee Act (GDUFA), is simple. In return for industry paying fees, FDA says it will be able to review applications more quickly, eliminate a huge backlog in applications, make improvements to its review infrastructure, and inspect generic drug manufacturers more regularly (thereby improving industry-wide compliance).

That's the intent, anyways.

But as with other user fee programs, the generic drug industry has front-loaded costs-the user fees-that it has paid in return for what are in effect promises of future performance from FDA.

So the perennial question posed by the industry is this: Is FDA holding up its end of the GDUFA bargain?

New Report

A new report issued on 3 February 2014 by FDA aims to answer that question, at least for the first year of GDUFA's operation.

In a statement accompanying the report, FDA Commissioner Margaret Hamburg said that her agency had met all its commitments for its first year under the program, and in doing so has "laid the foundation for future success."

"We are committed to meeting all GDUFA performance goals while, as always, maintaining a focus on ensuring that safe, effective, and affordable human generic drugs are reviewed in an efficient and predictable time frame," Hamburg said.

To date, FDA says it has managed to make "significant progress" in eliminating a massive backlog of ANDA applications.

"Of the 2,866 abbreviated new drug applications (ANDAs) and 1,882 prior approval supplements (PASs) pending on October 1, 2012, 868 and 752, respectively, received a first action (approval, tentative approval, CR, refusal to file (RTF), or withdrawal) as of September 30, 2013," FDA explained.

FDA has also already committed and awarded $17 million to advance what it called "regulatory science priorities," and has developed additional ones for 2014. GDUFA funding has also gone toward building new information technology systems to improve the efficiency of the drug review process, FDA said.

In addition, FDA said it has made improvements meant to "enhance the efficiency of the review process and improve the quality of human generic drug submissions." Those improvements include new guidance documents, new public resources to assist sponsors with meeting review standards, and instituting a new policy meant to communicate "easily-correctable deficiencies."

FDA also succeeded in hiring 31% of the anticipated GDUFA program staff, beating its goal of 25%.

The report does note, however, that most actionable goals, such as review-time goals, don't have measurable performance goals until FY 2015. At that time, FDA will be expected to make decisions on at least 60% of submissions within respective time allotments.


FY 2013: GDUFA Performance Report

Tags: FY 2013, Report, GDUFA

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