If you care about the drug industry, you’ll find this fascinating. Or if you care about patents and the drug industry.
One of the advantages of a patent is a monopoly. You’re the only one that can make a drug for a disease. Since finding a drug is difficult, frequently this means you’re the only one who can treat a disease.
Last June, Genzyme started facing some difficulties in their Allston, MA plant, which has led to a shortage of two drugs, Cerezyme and Fabrazyme ever since. This means that people with the diseases these treat, Gaucher and Fabry respectively, have either not received drugs or received lower doses.
This was a legitimate health crisis. So, the FDA looked in their pipelines and saw that Shire had drugs on the way for these diseases and allow them to be prescribed on an emergency basis without regulatory approval. They also fast tracked the treatment for Gaucher disease, meaning it has now been approved a year or more before it otherwise would have reached the market.
So, Genzyme not only squandered the monopoly opportunity of having the only drugs on the market to treat these diseases, but they also caused a health crisis that led to their period of monopoly being shortened.
Sucks to be a Genzyme shareholder right now. I’m actually kind of impressed with the FDA’s actions, but the whole situation presents some questions about drug patents. If there had been generics on the market, presumably some of them could have stepped up production. But if there wasn’t patent protection, the drug might not have been invented at all. I’m not quite sure what to think.