FDA says its new global pharmaceutical quality initiative will “deepen” its reliance on other regulators and will feature a new team dedicated to overseeing its mutual reliance work with the European Union.

The agency provided little additional insight into its plans, though, leaving questions on how the new project might enhance, complement or replace current efforts.

One potential outcome of the project may be FDA’s acceptance of European drug manufacturing inspections and greater harmonization of regulations.

The initiative will “further our goal of ensuring that the public has access to quality pharmaceuticals” and “aims to deepen our reliance on trusted regulators outside the United States who provide equivalent public safety and quality protection,” according to a May 12 internal memo to Office of Global Regulatory Operations and Policy, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research staff.

The memo was co-signed by FDA Deputy Commissioner for Global Operations and Policy Howard Sklamberg, CDER Director Janet Woodcock and CBER Director Karen Midthun.

“Harmonizing Our Standards”

The program will complement ongoing work of CDER, CBER, the Office of Regulatory Affairs and the Office of International Programs to enhance drug quality through international collaboration and FDA’s work in implementing the FDA Safety and Innovation Act, the memo adds.

The Global Regulatory Operations and Policy, CDER and CBER will jointly manage the initiative, which will build upon FDA’s existing work with the European Medicines Agency , European Union member states, the European Commission and European Parliament. It will also continue FDA efforts to enhance collaboration between its centers and ORA.

“The goal is to increase our exchange, with the EC and the EMA, of information that is critical to making decisions that protect the public health. And together we will be more efficient and effective in targeting our resources for inspecting pharmaceutical operations,” Sklamberg said in a same-day blog post discussing the project and FDA’s commitment to global pharmaceutical quality.

“Securing the global supply chain requires more than FDA presence abroad,” he said. He called for a cooperative, worldwide endeavor that involves working with regulatory counterparts to build capacity and “harmonizing our standards for the sake of safer products and greater efficiency.”

FDA Personnel Shifts

The mutual reliance effort is yet another major initiative Sklamberg has undertaken since becoming head of FDA’s Office of Global Regulatory Operations and Policy in January Also see "FDA Again Taps Compliance Director For Globalization Post" - Pink Sheet, 8 January, 2014.. He also is working on the recommendations of the agency’s Program Alignment Group, which could lead to broad assignment changes for the inspectorate ([A#14140204006]).

More than 40% of finished drugs are imported to the U.S. and about 80% of manufacturers of active pharmaceutical ingredients used in the U.S. are located outside the U.S., Sklamberg said, but he has been committed to making sure globalization is not a concern for consumers Also see "How FDA Plans To Stop Worrying And Love Globalization" - Pink Sheet, 17 March, 2014..

Dara Corrigan will lead the mutual reliance initiative as senior counselor for global operations and policy starting May 18; she will report to Sklamberg.

Corrigan, who currently directs FDA’s European Office in Brussels, will remain in Belgium and lead a team dedicated to mutual reliance, which will include Julie Zawisza, who has served as director of CDER’s Office of Communications since 2008, and Helen Saccone, a pharmacist who has been a special assistant in the Office of Manufacturing and Product Quality in CDER’s Office of Compliance since 2011.

Prior to leading the European office, Corrigan, who will bring a legal background to the job, was associate commissioner for regulatory affairs. Don Prater will replace her, serving as acting director, FDA Europe Office.

Details Still To Come

Further information on the program will be announced in later months as the team completes its first set of activities, the memo said. FDA plans to host a town hall for staff to ask questions.

EMA said FDA’s announcement is a positive follow-on to the EU and FDA’s bilateral meeting March 31 and April 1, “where drug supply chain challenges, including efforts to better leverage each other’s inspection resources, were a major topic for discussion.”

Like FDA, the European regulatory authority declined to offer additional details on the collaboration, but EMA’s April 22 report on the bilateral meeting indicates FDA and EMA also discussed opportunities presented by new U.S. drug legislation to explore sharing information in a more timely manner.

FDA’s ability to partner with foreign regulatory authorities to increase information-sharing and allow for recognition of foreign inspections got a boost in the most recent user fee renewal legislation, the Food and Drug Administration Safety and Innovation Act of 2012.

“We now have more than 60 agreements with foreign counterparts to share certain information in inspection reports and other non-public information that can help us make better decisions about the safety of foreign products,” Sklamberg said in his blog post.

“This type of collaboration not only increases our ability to evaluate pharmaceutical facilities, but allows experts to learn from each other. The result: an outcome whose sum total exceeds its individual parts.”

FDA and EMA collaboration is nothing new, but the limited details of this project hint that the two groups may be moving beyond working together and more toward true reliance on the other group’s work to avoid duplicating resources.

Other recent FDA/EMA collaborations include a December 2013 announcement that the agencies will collaborate and share information on inspections of clinical and analytical facilities that conduct bioequivalence studies submitted to support generic small molecule drug applications Also see "FDA/EMA Bioequivalence Collaboration Is Narrow In Scope, Wide In Reach" - Pink Sheet, 3 January, 2014..

The two groups also have shared information and worked together on pharmaceutical clinical trial site and study good clinical practice inspections since 2009, and offered to conduct joint good manufacturing practice inspections since 2009 Also see "EMA And FDA Co-Operate To Reduce GMP Inspections Burden" - Pink Sheet, 16 August, 2010..

FDA Plans To Rely On Non-U.S. Regulators In Global Drug Quality Initiative

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