Drug versioning and legal accountability for preventable product harms (12 March 2025)

Summary

One way pharmaceutical companies try to prolong revenue streams from their expensive brand-name drugs is by using various strategies collectively referred to as “product hopping.” Product hopping involves creating new formulations of existing drugs using the same active ingredients and then switching patients to the new product, often as generic competition is set to emerge. Product-hopping strategies include switching from a tablet to a capsule, switching from a short- to a long-acting form or incorporating new inactive ingredients. Some may offer incremental benefits, but all lead to greater spending by patients and the health care system.

A new form of product hopping—drug versioning—may have crossed a line at which the desire to maximise profits led to patient harm. Drug versioning is when a manufacturer delays a new version of an existing product to maximise profits from an older one. In this JAMA article, S. Sean Tu and Timothy Bonis describe at a recent California lawsuit against the pharma company Gilead, which is accused of delaying the release of a safer medication to treat HIV in order to maximise the profits from its existing licensed product. They look at the benefits of preventing unethical, negligent drug versioning, which include avoiding unnecessary patient deaths and enabling timely access to affordable generic medicines.