How the intended role of generic medicines is being undermined in America

The introduction of a generic medicine should, in theory, incentivise companies to lower the price of the original drug, creating healthy market competition. However, loopholes in the current system are halting market entry, and questions over drug quality and generic manufacturing mar the process still further. This article looks at the role of generics in the drug market, the current challenges and the solutions advised by experts.

Developing a new product in the pharmaceutical industry costs multiple millions, sometimes billions, of dollars and years of work. When a company gets a new drug approved it is given a patent by the US Food and Drug Administration (FDA).

In 1984, The Hatch-Waxman Act (or the Drug Price Competition and Patent Term Restoration Act) created incentives for generic drug makers to challenge drug patents that prevent competition. Successful challenges win a 180-day period of exclusivity where their generic is the only one able to compete before additional generics are allowed on the market. This is designed with the goal of lowering the overall prices of the drug. The Act also established a quicker and less costly path to FDA approval, which no longer has to go through expensive and lengthy clinical trials for their drug, and instead leant on the supporting data from…