Dr. Margaret (Peggy) Hamburg, former FDA Commissioner: “I hope we can come together around shared goals.”

Dr. Margaret (Peggy) Hamburg, former FDA Commissioner, describes the profound impact the HIV epidemic has had on her personally and in terms of her career choices. She discovered in her six years as FDA Commissioner how vitally important FDA is to the safety and protection of Americans, at home and abroad. FDA has oversight responsibility for fully 20% of the American economy. She is  deeply worried at the level of destruction visited upon FDA recently, but cautions that it is critical to wait until the dust has settled. “Corporate capture” of FDA has been an issue for a long time, tied to user fees and industry participation on advisory panels. What is most important is to engage the right expertise and experience, with effective guardrails. The Trump administration has instructed FDA to expand overseas unannounced inspections, expedite the creation of a centralized AI platform across all FDA units, and lower the barriers to the pharmaceutical industry building new facilities on US soil. In each of these ambitious goals, a step-by-step approach is needed, along with attention to the “disconnect” between big, new goals versus uncertain, or declining FDA capabilities in staff, financing, and dedicated offices. She is very concerned at the worsening threat to vaccines and the need somehow to earn back public trust. The same is true for the U.S. “biomedical research and innovation enterprise”—the envy of the world—that has been struck by a “wrecking ball.”