Healthcare DIVE December 4, 2019
In 2010, people with a rare enzyme disorder called Fabry found supply of the only treatment rationed. Those taking Genzyme’s drug Fabrazyme could only get a third of their normal dose, and new patients couldn’t get any.
The reason? Viral contamination at the company’s Allston, Mass. plant.
Patients on rationed doses suffering a resumption of symptoms like pain, high blood pressure and vision problems petitioned the federal government to invoke long-standing authority to “march in” to revoke Genzyme’s patent and give it to another company that could meet demand. The National Institutes of Health declined, reasoning that in spite of Genzyme’s clear mishandling of supply, it would take another drugmaker years of clinical work to catch up.
With the major...