Key keywords: FDA Commissioner Marty Makary, CNBC full exclusive interview, US FDA drug approval reform, public health emergency preparedness, over-the-counter (OTC) medication expansion, pediatric vaccine safety monitoring, healthcare supply chain resilience, rare disease treatment access, prescription drug cost reduction The full 45-minute CNBC interview with newly appointed FDA Commissioner Marty Makary, aired on October 12, 2024, offered unprecedented insight into the agency’s 3-year policy roadmap, addressing longstanding criticisms of bureaucratic delays, public health communication gaps, and unequal access to life-saving medical products across the U.S. During the sit-down with CNBC’s senior health and science correspondent Meg Tirrell, Makary opened by outlining his core priority: cutting the average novel drug approval timeline by 30% by 2026 without compromising safety standards. He noted that the current average 10-year approval cycle for rare disease therapies leaves thousands of patients with no treatment options, and the agency will roll out a fast-track pilot program for therapies targeting conditions with fewer than 10,000 diagnosed U.S. patients by the end of 2024, allowing for conditional approval based on phase 2 trial data for therapies showing statistically significant clinical benefit. Makary added that all conditionally approved treatments will be subject to strict post-market monitoring requirements, with immediate withdrawal authority for products that fail to meet long-term safety and efficacy benchmarks in phase 3 follow-up trials. Makary also addressed the growing public demand for expanded over-the-counter medication access, confirming that the FDA is reviewing 17 additional common prescription medications for OTC reclassification, including common allergy treatments, low-dose statins for heart disease prevention, and certain oral contraceptives, with final decisions expected by mid-2025. He emphasized that this move is projected to cut U.S. consumer out-of-pocket healthcare costs by an estimated $12 billion annually, by eliminating unnecessary doctor’s visits for routine, low-risk medication refills. On public health emergency preparedness, Makary acknowledged gaps exposed during the COVID-19 pandemic, including widespread supply chain shortages for diagnostic tests, personal protective equipment and generic medications. He announced a new public-private partnership program that will require 70% of critical medical supplies sold in the U.S. to be manufactured domestically by 2028, with tax incentives for pharmaceutical and medical device companies that shift production back to U.S. facilities. The interview also covered debates around pediatric vaccine safety, with Makary stressing that the FDA’s post-market safety monitoring systems have detected no widespread adverse events linked to routine childhood vaccines, and the agency will launch a new public transparency portal next quarter that publishes real-time safety data for all approved vaccines and pharmaceutical products, to rebuild public trust in FDA oversight.