Some observers have expressed concern about the recent appointment of Scott Gottlieb as head of the Food and Drug Administration because of his past work with pharmaceutical companies. However, it's important to remember that the FDA handles a lot more than drugs and biologics. In fact, addressing the Food Safety Modernization Act (FSMA) regulations will be a critical issue for Dr. Gottlieb.
A review of economic analyses written by the FDA to support many of its regulatory decisions in implementing FSMA shows that there were much better options on the table than those selected — options that would have lowered the cost of these regulations. To take just one example, the FDA chose to target all produce with a food safety rule using FSMA. Had FDA regulators focused instead on only those fruits and vegetables that have demonstrable risk, the resulting regulations would have been less burdensome and less costly.
