ASCO expresses deep gratitude to Margaret Hamburg, MD, for her 6 years of vision and progress as Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Hamburg, one of the longest-serving FDA commissioners, leaves a legacy of important advances in regulatory science and medicine. The tools available to oncologists to care for our patients, including both drugs and diagnostics, have expanded tremendously in the past 6 years as a result of Dr. Hamburg’s efforts.
“Under Dr. Hamburg’s leadership, we have made great strides in cancer treatment and in how we implement precision medicine,” said ASCO Chief Medical Officer Richard L. Schilsky, MD, FACP, FASCO. “Dr. Hamburg has been at the forefront of ensuring that the FDA is keeping pace with these rapid scientific changes and using available mechanisms to speed patient access to safe and effective therapies.”
Among her many accomplishments has been an increase in the speed and efficiency of medical product reviews, the expansion of FDA-expedited approval mechanisms, and the development of the Breakthrough Therapies designation for therapies to help patients with serious or life-threatening diseases. In 2014, nearly half of the novel new drugs approved received expedited approval, including drugs for cancer. Under her watch, the agency also established a regulatory pathway for biosimilar biological products, as well as approval of companion diagnostic tests that are used with targeted therapies to determine whether a patient will respond to a specific therapy. Dr. Hamburg has provided important leadership in the regulation of tobacco products, most notably extending regulatory authority to electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems (ENDS). She has also been instrumental in creating a culture of transparency and open-door involvement at the FDA.
“Dr. Hamburg laid the groundwork to ensure that these meaningful initiatives will continue past her tenure,” Dr. Schilsky said. “ASCO is grateful for her service to our country and to all Americans.” ■
