The US Food and Drug Administration (FDA) has announced a new initiative meant to improve the quality of pharmaceutical products by working more closely with a small group of trusted global regulators.

Background

Millions of US consumers take pharmaceutical products that originate-either in whole or in part-from foreign countries. And while FDA's budget for inspections has increased in recent years, trends in globalization have left it unable to inspect all manufacturing facilities on a regular basis.

In recent months, the global regulatory dialogue has been increasingly focused on pharmaceutical quality, particularly as FDA inspectors have uncovered data falsification practices at close to a dozen Indian pharmaceutical manufacturers.

In response to those concerns, FDA has been working to establish a new Office of Pharmaceutical Quality (OPQ), and has also begun a $20 million effort to test the safety and quality of generic drug products.

Notably, it's also begun to work with the European Medicines Agency (EMA) to share the results of their facility inspections, especially when that facility manufactures generic drug products. In a December 2013 announcement, FDA said the data sharing program, known as the Generic Drug Applications Inspections Initiative (GDAI Initiative), will allow both regulators to more easily take action against deficient manufacturing facilities.

New Quality Initiative

Now, US regulators have announced the formation of a new EU-based team meant to "leverage" its existing relationship with EMA and other EU regulators to boost drug quality on both sides of the Atlantic.

In an email to FDA staff on 12 May 2014, a trio of high-ranking FDA regulators-Janet Woodcock, Howard Sklamberg and Karen Midthun-said FDA was embarking on an as-yet unnamed initiative that will collaborate with EU regulators, the European Commission and the European Parliament.

Unlike its earlier GDAI Initiative, this one encompasses a more holistic view of drug quality, involving both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), as well as FDA's Office of Global Regulatory Operations and Policy.

The initiative will be managed "jointly" by all three offices, and will be led by Dara Corrigan, former associate commissioner for regulatory affairs. Corrigan had stepped down from her position in August 2012 to become director of FDA's Europe Office and a senior advisor for global operations.

Joining Corrigan will be Julie Zawisza, currently director of CDER's Office of Communications, and Helen Saccone, special assistant in the Office of Manufacturing and Product Quality (OMPQ) in CDER's Office of Compliance.

"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," FDA wrote in the email.

More information will be provided in the "coming months," the agency added.

Full Email Text

From: CDER Center Director
Sent: Monday, May 12, 2014 8:51 AM
To: FDA-CDER-wide
Subject: U.S. - Europe Mutual Reliance Activities

 

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