It’s been ten years since the FDA was given the mandate from Congress to fully regulate the tobacco industry and tasked with the critical responsibility of protecting the health of our nation. And still, the FDA has not fulfilled its mission to reduce the deadly toll of tobacco use.
FDA Commissioner Hamburg Leaving a Legacy of Patient Focus
Dr. Margaret Hamburg announced today that she is stepping down in March as Commissioner of the Food and Drug Administration (FDA). I want to pay tribute to her tireless efforts to advance the interests of patients during her six years at the FDA. Commissioner Hamburg has been a true champion in the fight against cancer. One of my lasting memories of Dr. Hamburg's influence is her work to address the drug shortage crisis in 2012. At a time when production problems caused a severe shortage of some commonly-used oncology drugs, the commissioner worked closely with patient advocacy groups and industry to find an alternate supply to ensure that patients had access to lifesaving therapies. Dr. Hamburg also leaves a legacy of greater patient engagement at FDA, including new patient-focused drug development meetings and the formalization of a patient network program. In addition, she increased the agency's scientific capacity and oversaw significant changes in the way promising drugs are approved. This includes implementing the rapid Breakthrough drug approval pathway, which was used for more than half of the cancer drugs approved in 2014. Under Dr. Hamburg's tenure, FDA has also moved to provide more oversight over important tests that often determine a patient's diagnosis and plan of treatment. All of these actions have greatly benefited cancer patients who seek the best, most effective treatments to fight their disease. I can't talk about Dr. Hamburg's contributions to patient care without mentioning the establishment of the agency's Center for Tobacco Products in 2009. Thanks to passage of the Family Smoking Prevention and Tobacco Control Act that year, the FDA could exercise regulatory authority over tobacco products for the first time in history. The Center, which became fully staffed with leading tobacco experts under Dr. Hamburg's leadership, issued important regulations of cigarettes and smokeless tobacco, and is in the process of finalizing its authority over all other tobacco products. Dr. Hamburg's departure should not delay the Center's work to develop new graphic warning labels for cigarette packs and to quickly regulate cigars, e-cigarettes and other unregulated tobacco products, which kill a total of nearly 500,000 people in America each year. Commissioner Hamburg's commitment to improving the lives of cancer patients and protecting the public from the hazards of tobacco use is unrivaled. I hope the momentum she has created to modernize the FDA and improve its responsiveness and quickness will continue under the agency's new leadership.