Hamburg leaves strong legacy of progress on many fronts
In her nearly six years at the helm of the U.S. Food and Drug Administration, Commissioner Margaret Hamburg has driven tremendous advances in the way the agency brings patients into the regulatory process, and ensures that their needs and input factor into decision making.
The long-time public health official, champion of patients and friend of FasterCures will be stepping down next month.
From the very beginning of her career, Hamburg has understood the importance of listening to individuals living with disease, and factoring their perspectives and experience into policy decisions. She was on the frontlines of the HIV/AIDS crisis and saw first-hand how patients can improve the research and development system. “It wasn’t that they were simply advocates. It was that they really were contributors and that they really brought a very sophisticated understanding,” said Hamburg in Back to Basics: HIV/AIDS Advocacy as a Model for Catalyzing Change, a report co-authored by FasterCures and HCM Strategists.
Under Hamburg’s leadership, the FDA has evolved into a more transparent, communicative agency that brings external stakeholders to the table earlier and more often. Among her many contributions are the launch of the FDA’s Advancing Regulatory Science initiative in 2010 (which developed better tools and standards for assessing safety and efficacy), the increased communication and collaboration between FDA and NIH, the launch of the PDUFA V-initiated Patient-Focused Drug Development Initiative (which invites patients to share their feedback on benefits and risks with the FDA), and multiple measures to speed the development and review of new drugs and devices.
Last year the FDA approved 41 new therapies, the most in almost 20 years, a testament to the impact of these efforts.
FasterCures congratulates Dr. Hamburg for her myriad contributions and tireless service, and looks forward to continuing to partner with the many strong leaders still within the agency who are working hard to propel medical progress forward in partnership with patients.