Statement by Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, Applauding FDA for Making GDUFA a Public Health Priority, Improving ANDA Submission Inquiry Communication

PRESS RELEASE

WASHINGTON, DC (January 31, 2014) — “The generic pharmaceutical industry and the Food and Drug Administration (FDA) share the view that the Generic Drug User Fee Act (GDUFA) and its obligations are a public health priority. The Generic Pharmaceutical Association (GPhA) applauds the FDA for committing to making the Abbreviated New Drug Application (ANDA) process more timely and predictable.

The intent of GDUFA is to speed consumer access to safe, lower cost generic medicines. The Generic Pharmaceutical Association (GPhA) commends the Office of Generic Drugs (OGD) for taking the appropriate steps to meet GDUFA goals, which will be measured in years 3-5.

With these communication enhancements to the ANDA review process, FDA continues to demonstrate its commitment to continuous improvement of the approval process. These changes are positive steps that can make it significantly easier for industry to assess the status of submissions, and improve market launch planning.

GPhA will continue working with the FDA’s OGD to improve process transparency and help patients, consumers, government, businesses and others gain timely access to more affordable medicine.”