Dear GO, CDER, and CBER staff:
We are pleased to announce an initiative to further our goal of ensuring that the public has access to quality pharmaceuticals. This initiative aims to deepen our reliance on trusted regulators outside of the United States who provide equivalent public safety and quality protection. This work is critically important and requires a dedicated FDA team to collaborate with our colleagues in European institutions and member states.
Managed jointly by GO, CDER, and CBER, this initiative will build upon our existing relationships with the European Medicines Agency (EMA) and member states of the European Union (EU), the European Commission (EC), and the European Parliament. It will complement the ongoing work of CDER, CBER, ORA, and OIP to enhance pharmaceutical quality through international collaboration, and also FDA’s work in implementing the FDA Safety and Innovation Act.
Dara Corrigan to Lead Initiative as Senior Counselor for Global Operations and Policy
Effective May 18, Dara Corrigan will lead this mutual reliance initiative. She will leave her position as director of FDA’s Europe Office, but remain in Brussels, in the role of senior counselor for global operations and policy. Dara will report directly to Howard Sklamberg, deputy commissioner for global operations and policy. She will provide strategic advice and counsel to the FDA Commissioner and other FDA senior executives. Don Prater, DVM, will serve as acting director, FDA Europe Office.
Dara brings a wealth of experience and knowledge of U.S. and EU laws and regulations that govern pharmaceutical products. Before serving as director of FDA’s Europe Office, she was FDA’s associate commissioner for regulatory affairs, overseeing one of FDA’s largest operating units and managing FDA’s inspection program. She also has held a variety of senior positions in HHS, and served as an attorney with the U.S. Department of Justice and at the law firm of Arnold & Porter.
CDER OCOMM’s Julie Zawisza and CDER OC’s Helen Saccone to Join Team
Dara will oversee a team that will be dedicated to mutual reliance activities and that will report to GO, CDER, and CBER. The team will include Julie Zawisza, who has served as director of CDER’s Office of Communications since 2008, and Helen Saccone, who has been a special assistant in the Office of Manufacturing and Product Quality (OMPQ) in CDER’s Office of Compliance since 2011.
Julie holds a master’s degree in international science, technology, and public policy from the George Washington University and has more than 14 years of FDA experience. Before working in CDER, she worked in communications at CBER and was the head of FDA’s press office in the Office of the Commissioner. Julie also has worked for health professional and industry associations in communications and advocacy roles, and as a medical technologist at major medical centers in Washington, D.C. and Ann Arbor, Michigan.
Helen Saccone, Pharm.D., has worked in FDA for six years. Before coming to FDA, she worked as senior manager for education at the American Pharmacists Association and as a pharmacist for the D.C. Department of Health, conducting pharmacy and hospital inspections, as well as providing technical assistance on D.C. regulations. She holds a doctoral degree in pharmacy from Rutgers University. The team also will draw upon the work of other experts in CDER, CBER, ORA, OIP, and OCC.
We are delighted that these seasoned and accomplished individuals have agreed to lead the charge, and we have every confidence that the program is in very capable hands going forward. We invite you to congratulate Dara, Julie, and Helen, and offer them your support.
Building on Existing Pharmaceutical Quality Efforts
We want to thank our FDA staff members who continue to work so diligently on improving pharmaceutical quality and safety for the American public. The initiative announced today builds on the Agency’s ongoing efforts to enhance collaboration between FDA centers and ORA, and to bolster our resources around drug quality.
We are very excited about this programmatic direction and its potential to leverage our relationships with our European partners and capitalize on our shared interests as regulators to strengthen mutual reliance and ensure pharmaceutical quality for the U.S. market.
In the coming months, you'll hear more about all of this as the team embarks on its first set of activities. A special town hall will be scheduled soon to give FDA staff an opportunity to ask questions about this initiative and how it fits in with the Agency’s pharmaceutical quality efforts.
Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy
Janet Woodcock, Director, Center for Drug Evaluation and Research
Karen Midthun, Director, Center for Biologics Evaluation and Research