FDA Reopens Public GDUFA Comments Docket

February 12, 2015

The FDA is giving industry until March 9 to weigh in again on the controversy surrounding generic first-filer exclusivity determinations and other GDUFA-related issues first raised at a September public hearing.

The agency reopened the public docket on the September hearing last week after receiving additional requests to be heard. During the hearing, generics makers complained of slow ANDA approval times jeopardizing first-filer eligibility, a lack of communication between the FDA and industry, lack of information in an inactive ingredients database and the ANDA backlog itself, among other issues.

In addition to first-filer exclusivity, the FDA now wants feedback on five draft guidances issued under the 2012 Generic Drug User Fee Amendments, which seeks to speed ANDA approval by charging filers for facilities and drug applications. The guidances cover content and format of ANDAs, refuse-to-receive criteria for inadequate impurity limit justification, amendments and easily correctible filing deficiencies, prior approval supplements and controlled correspondence.

The agency also wants to know if there are GDUFA implementation issues related to the guidances that have yet to be addressed, if any other outstanding GDUFA implementation issues are in need of guidance and if there are generic drug issues in need of guidance outside of GDUFA.

For first-filer exclusivity, the FDA is again asking if the considerations should be part of a public process and if there are better legal or regulatory mechanisms to resolve court challenges to exclusivity determinations.

Another topic that came up in September, regarding how the FDA will consider so-called “first generics,” is now part of a separate docket for which the agency said it is not seeking additional input.

The comments will be weighed as the FDA develops its fiscal year 2015 GDUFA priorities.

See the Federal Register notice here: www.fdanews.com/02-06-15-GDUFAComments.pdf. — Bryan Koenig