FDA, GPhA Reaffirm Shared Commitment to GDUFA

PRESS RELEASE

WASHINGTON, D.C. (Feb. 20, 2014) — Today, FDA Office of Generic Drugs Acting Director Kathleen Uhl, M.D., highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act (GDUFA) milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place in Orlando.

The Generic Pharmaceutical Association (GPhA) also today launched a new digital library and online educational resource, www.GDUFAnow.org, a new tool to enhance awareness and ease industry familiarity with GDUFA responsibilities.

“GDUFA is a historic achievement and shared commitment for the FDA and our industry,” said Ralph G. Neas, President and CEO, Generic Pharmaceutical Association. “GDUFA is supported 100 percent with industry generated funds. Indeed, efforts to ensure safety, increase access to generics and enhance transparency are top priorities for the Association. This new online resource highlights regulatory developments, compliance requirements and more - putting all of the critical information in one easy to find location.”

These commitments were also noted during a panel titled, GDUFA: Promise and Progress, moderated by Marcie McClintic Coates, J.D. , Vice President and Head of Global Regulatory Affairs at Mylan, and featuring Kate Beardsley of Beardsley Law PLLC, Sheldon Bradshaw of Hunton & Williams LLP and Gordon Johnston of Gordon Johnston Regulatory Consultants.

As FDA Commissioner Hamburg relayed from India in a recent FDA Voice post: “FDA is working quickly to fulfill one of our commitments under (GDUFA) — reducing the backlog of generic drug applications. As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45 percent of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs. GDUFA also requires that we step up our number of foreign inspections and gives us the funding to do so.”

“To make GDUFA a success, we must act now and stay informed. To speed and enhance the approval process, we must equip FDA with the resources it needs. Working together, we can ensure that millions of Americans, and indeed, patients around the world, continue to receive the timely access to safe, effective and affordable generic drugs that they rely on,” said Neas.

For more information, visit www.gdufanow.org.