The Food and Drug Administration (FDA) and the generic drug manufacturing industry including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient 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.
WASHINGTON, DC (Aug. 31, 2016) — The Food and Drug Administration (FDA) and the generic drug manufacturing industry —including representatives of generic pharmaceutical manufacturers, active pharmaceutical ingredient 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.
Statement by David Gaugh, Senior Vice President, Sciences and Regulatory Affairs, GPhA:
“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:
• GDUFA Backlog ANDA Provisions
• Priority and Standard Review
• Enhanced communication and transparency
• Complex Product Meetings
• Enhancements to the Inactive Ingredient Database (IID)
• Resource Management and Planning and Performance Reporting
• Small Business Relief
GPhA 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.
GPhA is hopeful that these updates will help the agency take stronger steps to expedite the review and approval of generic drug applications, an effort that boosts generic competition and helps increase patient access to more affordable medicines.
GPhA welcomes the opportunity to continue working with FDA to ensure the success of the collaborative effort that makes timely access to generic drugs possible for millions of Americans.”