Lawsuit Against Drug Company Could Quash Future Cures

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Sally C. Pipes is president, CEO, and the Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All, (Encounter 2020). Follow her on Twitter @sallypipes.

Like most pharmaceutical companies, Gilead Sciences Inc. devotes a huge amount of time and money to making sure its products are safe for patients. The U.S. Food and Drug Administration approved its drugs to fight HIV, and these medications have worked remarkably well. It then developed the next generation of HIV medications, and those too have worked well.

This reasoning is not just bizarre but dangerous. If successful, the lawsuit could discourage scientists and product developers at all sorts of companies—from startups to drugmakers to industrial manufacturers—from trying to create safer, more effective products. An enormous amount of research and testing is required before a drug can be deemed safe for public consumption. Indeed, the FDA requires multiple rounds of clinical trials and regulatory review of everything from a drug candidate's label to the places where it will be manufactured before it will consider approval.

There's no reason to think that the path of even a"kinder, gentler" tenofovir would have been any easier.

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