In this analysis, we examine how a system designed to increase patient access to affordable medicines accomplished what most other nations thought impossible Yet, a deeper examination reveals how even the best-intentioned systems can fall prey to emergent incentive structures, becoming gradually unmoored from their original purpose.

When we pick up our medications at the pharmacy, most of us do not pay mind to where they were made. If we notice that the pill bottle appears slightly different since the last refill, the doctor will tell us not to worry. Channeling guidelines from the highest medical authorities, the healthcare professional safely assumes that the drug is essentially the same, regardless of its manufacturer.

This axiom of pharmaceutical bioequivalence has been a pillar of the medical system for decades, but mounting evidence calls for a reexamination. The Food and Drug Administration explains the essence of the principle under scrutiny:

This claim encountered its first major challenge with Katherine Eban’s 2019 book, Bottle of Lies. Her investigation followed industry veteran Dinesh Thakur as he unmasked systemic data fraud at Ranbaxy Laboratories, India's largest generic drug manufacturer that was a key supplier to the United States. The company insider felt compelled to blow the whistle since he feared that low quality manufacturing was leading to millions of patients taking dangerously compromised medicines, from common antibiotics to AIDS treatments. Far from an isolated case, the book meticulously documented evidence of systematic failures at the FDA, the agency responsible for ensuring the integrity of all medicines produced, both at home and abroad.

After launch, expectations were high for a reckoning that would user in reforms to ensure that reality lived up to promise. Over five years later, it is apparent that no such reform ever took place.

Most physicians are aware of the central role that generic drugs play in the healthcare system, representing over nine out of 10 prescriptions they write. A disruption to the status quo would be felt far beyond the doctor's office, ushering in a cascade of unprecedented challenges to the web of institutions that make the healthcare system run.

This raises the question, then, if reality is truly different than official policy portrays, then what explains the lack of action to address the problem?

This article will build on the foundation set by Eban to highlight more recent developments and provide an overview of the current system, leading into potential solutions. In order to understand the proposals in the complex landscape we are dealing with it, one must understand not just how the system came to be but how the structures embedded inside cause and sustain the problem.

This article was written in consultation with leaders and operators in the healthcare system, academics and experts in healthcare policy, and medical professionals.