FDA, Industry Reach Agreement on GDUFA Reauthorization

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 09-01-2016 18:01


The US Food and Drug Administration (FDA) and the generic drug manufacturing industry —including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient (API) manufacturers, and contract manufacturing organizations — have reached agreement on a package of program enhancements and resource commitments to reauthorize the Generic Drug User Fee Amendments of 2012 (GDUFA), which are set to expire next year.

Under GDUFA, the industry is required to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. These additional resources were intended to support the FDA's efforts to reduce a backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections. GDUFA is also designed to enhance global supply-chain safety by requiring that generic drug facilities and sites around the world self-identify. The current legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. 

In a statement by David Gaugh, senior vice president, sciences and regulatory affairs, Generic Pharmaceutical Association (GPhA) said: “GPhA and its members are pleased to conclude the first reauthorization negotiations to update the Generic Drug User Fee Amendments (GDUFA). The commitments outlined in GDUFA II enable the FDA to continue delivering on its promise to protect public health by ensuring access to safe and effective generic medicines. The generic drug review process is largely supported and funded by industry stakeholders. These funds are applied toward streamlining and expediting the application review and approval process, improving regulatory consistency and predictability, and ensuring that millions of patients have timely access to safe and effective generic medicines."

Key provisions of GDUFA II include, according to GPhA: GDUFA backlog abbreviated new drug application provisions; priority and standard review; enhanced communication and transparency; complex product meetings; enhancements to the Inactive Ingredient Database; resource management and planning and performance reporting; and small business relief.

GPhA said it is "optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all ANDAs to assure that no submissions from GDUFA I are left behind. It will also provide the FDA with additional resources, improving transparency and accountability in order to enhance the ability of the FDA to meet GDUFA II goals. Process changes and staff additions have been positive steps thus far, and the addition of enhanced performance reporting sets an even stronger foundation for translating FDA actions on generic applications to approvals."

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), also welcomed the successful ending of negotiations for the reauthorization of GDUFA II BPTF is an industry trade organization for API manufacturers, their intermediates, and excipients that market in the U.S. Created in 2002 as an affiliate organization of SOCMA, its objective is to seek clarification of current regulatory requirements and to interact with governmental agencies on emerging issues.

Key for the BPTF are provisions under GDUFA designed to achieve parity of risk-based inspection frequency between foreign and domestic manufacturers and enhance FDA’s ability to identify and track registration of manufacturers of drug products sold in the US.

“We thank the FDA for their leadership in the negotiations, and we are pleased with the agreement we were able to reach on this important public safety issue,” said John DiLoreto, executive director of BPTF. “This new plan is not only good for the generic drug industry, but it will also benefit consumers by making safe drugs available faster. We are particularly pleased with the changes made in the new agreement that will benefit small businesses.”

Source: FDA, GPhA, and SOCMA


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