David Martin, M.D., M.P.H.
Cars driving on the left side of the road and exhortations to “mind the gap” when exiting the underground became a part of my daily routine when I joined the FDA Office of International Programs as the Acting FDA Liaison to the European Medicines Agency (EMA) in London. EMA is an important partner for the FDA: It coordinates a network of 4,500 European scientists and evaluates and supervises human and animal medicines for more than 500 million people in 31 countries.
On my first day at the EMA, I learned that its Pharmacovigilance Risk Assessment Committee (PRAC) was debating a suspension of the European marketing authorization for a product approved in the United States by FDA. Moreover, PRAC was seeking urgent action within a week, which required quick response by FDA. Without it, suspension of a marketing authorization by Europe for an FDA-approved product could be confusing to patients, medical care providers, and industry in the U.S.
Consulting with management, review team members, and the international team from the FDA Center for Drug Evaluation and Research (CDER), I described the decision points to be addressed by the Europeans. The CDER team was already conducting a preliminary epidemiologic analysis of the possible relationship between the product and the adverse event in a large U.S. medical claims database. EMA had been already made aware of the ongoing CDER analysis, but needed formal detailed information to include in its benefit/risk assessment. PRAC had to be briefed on the broad outlines of the FDA evaluation within 48 hours, and needed access to FDA’s interim analysis within two weeks.
After a quickly arranged briefing under the auspices of an FDA-EMA confidentiality arrangement, CDER completed and shared the analysis in less than one week. At a follow-up meeting, FDA, EMA, and PRAC experts reviewed all data sources. The information indicated that the benefits of the product outweighed the low potential risk of adverse events. This information was included in the formal review by the PRAC, and a majority of PRAC members voted to maintain the product’s marketing authorization.
This episode showed the importance of reciprocal FDA and EMA representation at each agency, which is currently carried out by EMA’s Sabine Haubenreisser, MSc, Ph.D. in FDA’s headquarters in White Oak and FDA’s Amy Egan, M.D. in London. Contacts between the liaisons and host agency leadership facilitate strategic dialogue that informs future policy making. And through close observation of the U.S. and European regulatory agencies in action, the FDA and EMA liaisons can help both sides find common ground when they are faced with regulatory decisions that could impact global public health.
David Martin, M.D., M.P.H., served as the Acting FDA Liaison to the European Medicines Agency from June through September 2014. He is the Director of the Division of Epidemiology within FDA’s Center for Biologics Evaluation and Research.
About EMA: European Medicines Agency
EU facts and figures: European Union
EMA/FDA confidentiality agreement: International Programs