FDA reaches agreement on GDUFA amendments for new five-year term

Published: 1-Sep-2016

Will enable the FDA to ensure access to safe and effective generic medicines

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

'GPhA and its members are pleased to conclude the first reauthorisation negotiations to update the Generic Drug User Fee Amendments,' said David Gaugh, SVP sciences and regulatory affairs, GPhA.

'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.'

Gil Roth, President of the Pharma & Biopharma Outsourcing Association (PBOA) also noted the successful conclusion of the GDUFA II negotiation.

'We believe that industry, the FDA and patients will see great benefits from the programme during the next five-year period,' he said.

'PBOA’s presence at the negotiating table ensured that contract manufacturing organisations were represented in the new iteration of this critical programme.'

We believe that industry, the FDA and patients will see great benefits from the programme during the next five-year period

The GPhA said it is optimistic that the provisions of this agreement will streamline approvals by assigning goal dates to all Abbreviated New Drug Approvals (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 to enhance the ability of the FDA to meet GDUFA II goals.

Process changes and hiring more staff have been positive steps so far, and the addition of enhanced performance reporting sets a stronger foundation for translating FDA actions on generic applications to approvals.

GDUFA I was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act with the goals of improving safety, access and transparency within the generic sector.

The new version of this industry-funded programme includes key improvements, metrics and resource provisions intended to streamline the review process for Abbreviated New Drug Applications (ANDAs), enhance FDA’s inspection infrastructure and increase accountability, while providing relief for small businesses.

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