Can We Trust the FDA? Marty Makary on Science, Power & Patients

What It Covers

FDA Commissioner Marty Makary details his first year transforming the agency through 42 major reforms, accelerating drug approvals from years to weeks, eliminating animal testing requirements, removing petroleum-based food dyes, and restructuring vaccine schedules based on international standards.

Key Questions Answered

• •Drug Approval Acceleration: FDA reduced pivotal trial requirements from two to one, saving companies $100-300 million per drug. New pilot program delivers approval decisions in 55 days versus traditional 10-12 years. Eliminates 144 chimpanzee studies previously required for monoclonal antibodies, using computational modeling instead.
• •Biosimilar Revolution: FDA cut biosimilar approval timeline from 5-8 years to 2.5 years and reduced development costs by over $100 million. This targets biologics representing 51% of fastest-growing drug spending. Changes mirror small molecule approval principles, enabling competition with $60,000-150,000 medications like Humira.
• •Vaccine Schedule Reform: US reduced recommended childhood vaccine doses from 72 to 38 core essential vaccines, aligning with 20 developed countries studied. Hepatitis B vaccine no longer pushed for newborns with negative mothers. Aims to rebuild public trust after vaccination rates dropped during COVID-19 pandemic.
• •Food Pyramid Overhaul: New guidance prioritizes protein intake, reverses 50-year saturated fat dogma that led to 60-70% of children's calories coming from refined carbohydrates. Addresses 38% of kids having prediabetes or diabetes. Eliminates all nine petroleum-based artificial dyes banned in other countries but allowed in US.
• •Drug Pricing Strategy: Most favored nation pricing brings GLP-1 drugs from $1,300 to $149 for three months, matching lowest developed world prices. US previously financed 60% of global pharmaceutical R&D costs. FDA pushing more prescription drugs to over-the-counter status to enable price transparency and bypass pharmacy benefit manager markups.