FDA process

The FDA process and its impact on innovation have been topics of discussion on the My First Million podcast.

1. Sam Parr and Shaan Puri address how the Food and Drug Administration (FDA) has delayed actions on regulating harmful chemicals in everyday products. They mention that the FDA has been slow in addressing the risks posed by substances like PFAS in consumer goods, and how regulatory changes are now prompting shifts in manufacturing and product safety standards 1.

2. Balaji Srinivasan elaborates on the regulatory hurdles posed by the FDA. He argues that the FDA acts as a significant barrier to medical innovation not just in the U.S. but globally. Srinivasan highlights that the FDA’s risk-averse nature leads to both Type I (false positive) and Type II (false negative) errors, where potentially life-saving drugs and vaccines may be delayed or not approved. He compares this regulatory bottleneck to the broader financial innovations that bypass traditional systems, suggesting a parallel need for exiting the FDA, similar to how Bitcoin allows for exiting traditional financial systems 2.

These discussions underscore the complex role of the FDA in balancing safety and innovation, often sparking debates on the optimal level of regulation in healthcare and consumer safety.