The US FDA, which had released the Generic Drug User Fee Amendments (GDUFA) of 2012, has now issued a guidelines with queries and responses for industry to ensure transparency and facilitate compliance. In this regard it has also called for an industry meet to gather input on the guidance documents only to ensure early and streamlined implementation efforts.

The guidance provides answers to anticipated questions from generic drug industry participants regarding the implementation of the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), referred to as GDUFA. The format has grouped categories likes fees, self-identification of facilities, sites and organizations, review of generic drug submissions, inspections and compliance.

GDUFA is designed to speed up the delivery of safe and effective generic drugs to the public and reduce costs to industry. It is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges.

For over 25 years, the generic drug industry has been a public health success delivering lower-cost, bioequivalent versions of brand name drugs to the public. The industry’s success has, however, posed significant regulatory challenges. As the volume of new generic drug applications has increased and the industry has expanded globally, the time required for scientific review and inspections has grown, and with it, the backlog of pending generic applications. Now the GDUFA aims to put FDA’s generic drug programme on a firm financial footing and ensure timely access to safe, high-quality, affordable generic drugs, stated the regulatory authority.

GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs programme, bringing greater predictability and timeliness to the review of generic drug applications.

GDUFA will also enhance FDA’s ability to protect the industry in the complex global supply environment by requiring the identification of facilities involved in the manufacture of generic drugs and associated active pharmaceutical ingredients (API).

The new requirements in GDUFA will also ensure that foreign and domestic industry participants in the US generic drug system are held to consistent, high-quality standards and inspected biennially, with comparable rigor and frequency, using a risk-based approach.

Further, the GDUFA programme is designed to build on the success of the Prescription Drug User Fee Act (PDUFA) programme which over the last two decades has ensured a more predictable, consistent and efficient premarket review program for new drug applications (NDAs) and biologic license applications (BLAs). It has helped speed access to new, safe and effective prescription drugs to the public, stated the regulator.

Although modeled on PDUFA, GDUFA reflects the needs and challenges of generic drug regulation. GDUFA requires that FDA and human generic drug manufacturers alike must meet certain requirements. In a Commitment Letter that accompanies the legislation, FDA committed to review and act on 90 per cent of original, unamended abbreviated new drug applications (ANDAs) within 10 months following the date of submission by year five of the programme. It is expected to reduce the overall expense of bringing a generic product to market.