Dive Brief:
- The Food and Drug Administration issued final guidance for companies seeking to amend submitted abbreviated New Drug Applications under the Generic Drug User Fee Amendments (GDUFA II), coming after publication of drafts in October 2017.
- The guidance explains how amendments to ANDAs will affect GDUFA review goal dates, and simplifies and clarifies the classification of different types of amendments.
- The effort is part of FDA Commissioner Scott Gottlieb's Drug Competition Action Plan and seeks to streamline the ANDA process, make the requirements clearer and improve patient access to medicines.
Dive Insight:
As the costs of branded medicines climb, generic sales are soaring in the U.S. In its 2017 Generic Drug Access and Savings in the U.S. publication, the trade group Association for Accessible Medicines reported that almost 3.9 billion generic prescriptions were dispensed in 2016, with savings of $253 billion in 2016 alone, and $1.67 trillion over the last decade. Overall, generics make up 89% of prescriptions but just 26% of drug costs.
The FDA approved 763 abbreviated New Drug Applications in FY 2017, up from 651 in FY 2016, and 330 in FY 2013. FY 2018 approvals are already at 496.
However, the generics industry has been facing similar struggles to its branded counterparts. There has been increased pushback to rising prices and increased competition has meant a rough time for generic manufacturers, resulting in further consolidation.
GDUFA II, the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022, was signed into law in August 2017. It aims "to facilitate timely access to quality, affordable generic medicines." The new guidance follows up FDA promises for reviews made under GDUFA II, and supersedes the 2001 guidance and 2014 draft guidance.
Each submission to an ANDA under review is considered an amendment. Under GDUFA I, amendments were classified using a complex tier system, which included factors such as the number of amendments made, whether these were major or minor, and whether the amendments had been requested or not. GDUFA II and this guidance has made things simpler. Amendments will now be classified as major or minor, and deemed to be standard or priority, and the GDUFA date is then granted.