Supply Chain Transformation, 503B And Reducing Drug Shortages

By Kurt R. Nielsen, Ph.D., President and CEO, Pharmaceutics International, Inc (Pii)

Currently there are two great forces at work that are disrupting traditional models for advancing drug therapies from discovery to commercial production and distribution. This transformation, when complete, will impact the biopharmaceutical supply chain significantly and potentially achieve outcomes that were considered impossible a short time ago.

The first is scientific innovation which the industry has been talking about for a while. These healthcare innovations, driven by advancements in clinical pharmacology, are being introduced at an unprecedented pace.

The second is not something we anticipated: the urgency with which treatments and vaccines are being developed to combat the COVID-19 pandemic. If a vaccine is ready by early 2021, as many experts believe, it will be completed in a period of time like nothing we have experienced before.

At the same time that these two powerful forces are transforming healthcare and specifically drug therapy development, manufacturing and distribution to patients, FDA has been also improving Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The improvements are intended to advance FDA’s public health mission to reduce drug shortages and establish a regulatory environment that helps accelerate innovative therapies reaching the patients that need them most.