Mikkael Sekeres, M.D., is professor of medicine and the chief of the Division of Hematology at the Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine. He has a medical degree and a master’s degree in clinical epidemiology from the University of Pennsylvania School of Medicine and completed his postgraduate training at Harvard University. Sekeres is also the author or co-author of more than 400 scientific manuscripts on cancer. He is on the editorial board of several journals, has written 60 essays for Nouvèl Èdikay, and authored eight books, including When Blood Breaks Down: Life Lessons from Leukemia. The Food and Drug Administration has been frequently in the headlines recently, but few of us know much about how the agency works. Drugs and the FDA: Safety, Efficacy, and the Public’s Trust (The MIT Press), tells the story of how the FDA became the most trusted regulatory agency in the world. Before it existed, drugmakers could hawk any potion, claim treatment for any ailment, and make any promise on a label. But a series of tragedies, health crises, and patient advocacy forced the government to take responsibility for the efficacy and safety of drugs and medical devices. In 2011 the Avastin hearings tested a century of the FDA’s evolution, demonstrating how its system of checks and balances works – or doesn’t.