Breaking the Rules

Published on: 
BioPharm International, Biopharm International, December 2021 Issue, Volume 34, Issue 12
Pages: 4

We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

We have been living through a period where institutions and rules are being questioned. I am proud to work in an industry where colleagues, rules, and institutions have stood up well through this conversation. Some rules were deliberately broken, some barriers reduced. One concrete example comes from FDA guidance documents on abbreviated new drug applications where bioequivalence studies for generic drugs resupply with expired batches were deemed permissible “as long as sufficient evidence can be provided to demonstrate the acceptability of the test product batch” (1). Supply chain contingencies immediately transformed from an abstract concept to a concrete process for most of us.

Regarding investments in technology, a survey from Zebra Technologies reported that 86% of patients agree that increased technology spending would provide a competitive edge in managing pharmaceutical supply chain stability, security, and traceability (2). That number rises to 92% when answered by industry decision makers. Of these decision makers, 96% then consider supply chain visibility confers on them a competitive advantage. Key areas targeted for future spending for these decision makers are location technology, temperature monitor and sensors, temperature sensitive labels, prescriptive analytics, and machine learning. The findings continue, stating, “compliance remains an issue for the pharmaceutical industry. About one third of industry decision makers surveyed rank compliance among the top five challenges facing their industry today. Among the pharmaceutical industry verticals, manufacturing experiences the most significant lag in compliance.” Institutions and rules held up well during this time of emergency. We have learned what areas of our manufacturing supply chain held up, while also learning which areas we need to strengthen.

While not everything went smoothly over the past two years, we have manufactured great outcomes from alarming adversity. Nearly eight billion doses of COVID-19 vaccines have now been administered (3). We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.


  1. FDA, Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers, Guidance for Industry (FDA, September 2021).
  2. Zebra Technologies, Pharmaceutical Supply Chain Vision Study: Technology-led Transparency Drives Resiliency, Industry Study (November 2021).
  3. Bloomberg, “More than 7.84 Billion Shots Given: COVID-19 Tracker,” Vaccine Tracker, Last Updated Nov. 25, 2021.

Article Details

BioPharm International
Vol. 34, No. 12
December 2021
Pages: 4


When referring to this article, please cite it as C. Spivey, “Breaking the Rules,” BioPharm International 34 (12) 10–14 (2021).