Highlights of FDA Mutual Alliance Initiative

Dr. Dara Corrigan, FDA’s Associate Commissioner for Global Regulatory Policy in the Office of Global Regulatory Operations and Policy, delivered the first of two keynote addresses at the opening session of the ISPE/FDA/PQRI Quality Manufacturing Conference, 6 June 2016. Dr. Corrigan spoke about the FDA Mutual Alliance Initiative, a collaboration with the European Union (EU) to ensure that the public has access to quality pharmaceuticals. “Globalization has informed the work we do,” she said. “It’s changed the way we operate and the way we look at challenges.” FDA regulates products from more than 150 countries; 40% of finished drugs and 80%–85% of APIs come from outside the US. “FDA can’t be the inspectorate for the world,” Corrigan said. “It’s important to rely on others, and use limited resources to target the greatest risk.” To that end, she explained, “the agency is trying to identify other regulatory partners with whom we can join forces and that are capable of enforcing our standards.” In 1998, the US and EU agreed to respect each other’s GMP regulations, and in May 2014 began to determine if they could rely on each other’s inspection information, as well. “We knew we had to figure out a way to get this done,” Corrigan said. The EU employs an audit system in which two member states review a third state’s inspectorate, using a standard 78-item checklist.

FDA was allowed to observe these audits in 2013. To date, FDA has observed eight audits—in Sweden, Greece, Croatia, Germany, Hungary, Italy, the Czech Republic, and the United Kingdom. By the end of 2016, regulators will have observed over half of the EU states. The agency will continue to observe audits of other member states this year and in 2017. The EU audited the FDA in 2015, visiting three district offices, the agency’s main campus, and a drug lab. In another part of the FDA Mutual Alliance Initiative, FDA is figuring out how to share unredacted inspection reports with the EU. When the agency compared redacted to unredacted reports, Corrigan said, “we realized that without this [unredacted] information the other country wouldn’t be able to identify trends. It would affect public health.” In 2012, US law changed to permit this, under limited circumstances. “The history of audit review has changed FDA,” Corrigan said. “This should reduce the number of inspections in the EU, and free resources to do inspections in other places.” The real goal, she explained, is a unified virtual inspectorate that would share data and diminish public health threats worldwide. “FDA must engage their global partners,” she said. “There is a need for change and need for action. This year that change is going to happen.” Learn more about the FDA Mutual Alliance Initiative.