United States Food and Drug Administration (FDA) has now given a two-week extension for self identification process under the GDUFA (generic drug user fee amendment) regulations till December 18, 2012. This is because the regulatory authority has found that over 17,000 production plants globally including in India engaged in the manufacture of generics and active pharmaceutical ingredients which have gone in for mandatory self identification process, have still not undertaken the procedure as per the guidelines.
The FY 2013 reporting period for facility self-identification closed on December 3, 2012. Under the statute, generic drug products manufactured in facilities that have not self-identified, and active ingredients manufactured in facilities that have not self-identified, are misbranded. FDA is announcing, however, that there will be a two-week grace period, until December 18, 2012, in which facilities that have not yet successfully completed the self-identification process may do so without penalty.
The two week grace period should enable facilities that have not yet self-identified to do so. FDA does not want to set higher annual facility fee rates than necessary, based on an artificially low industry reporting base, stated the regulatory authority.
The industry has now been called upon to carefully go through the requirements on who must self-identify, type of information to be submitted and the process of presenting the same as per the rules.
To date, more than 1,700 facilities have self-identified for FY 2013. However, the regulatory authority is of the view that the figure is less than the universe of generic drug facilities. An analysis of facilities identified in Abbreviated New Drug Applications (ANDAs) and Prior Approval Supplements (PAS) submitted since October 1, 2012 indicates that one out of eight facilities has failed to self-identify. If uncorrected, this trend will result in higher individual facility fee amounts.
“Now the two week extension is a breather for the industry. In fact, during this interim period industry can clarify issues for the right implementation of the guidelines,” said Kaushik Desai, immediate past president, Industrial Pharmacy Division, Indian Pharmaceutical Association.
On July 9, 2012, the GDUFA 2012 legislation designed to speed the delivery of safe, high-quality, and affordable human generic drugs to the public and reduce costs to industry became a law and was effective from October 1, 2012. It was then accompanied by enactment of related legislation: FDA User Fee Corrections Act of 2012, which enables the US FDA to collect and spend the full $299 million authorized in fiscal year (FY) 2013 by GDUFA user fees to fund program enhancements.
GDUFA requires the identification of facilities involved in the manufacture of human generic drugs and associated active pharmaceutical ingredients. The self-identification is required to determine the number of facilities required to pay annual facility user fees. The process of self-identification was also recognized as a central component of an effort to promote global supply chain transparency and facilitate inspections and compliance.