FDA Approves First Drug Made in a Mammal
The Food and Drug Administration gave a thumbs up today for ATryn, a blood-thinning drug produced in the milk of genetically engineered goats. As we’ve previously described, it’s the first drug made in the milk of a farm animal to get U.S. marketing approval. (Most meds are made in chemistry labs or inside genetically engineered bacteria.) And it comes less than three weeks after the FDA released final guidelines on what kinds of assurances of safety and efficacy will be expected of companies that make medicines this way.
If that seems quick to you (how could a company pass muster just a few weeks after the ground rules were released?) you are right. In fact, by approving the drug without having at least one public meeting devoted to important environmental, animal welfare, and other issues, the agency broke its own promises of how such approvals will be handled. Word on the street was that Atryn’s maker was in need of a positive nod from the FDA to help it get some investor dollars. Well, we wish the company well. But we also hope that the agency gets back on its own track with future applications, which are anticipated to encompass not only medicines made in animals but also gene-altered animals that themselves will be marketed for human consumption.
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