Posts
Fabry's disease is a rare, life-threatening genetic disorder for which the only FDA-approved treatment is Fabrazyme from Genzyme (now owned by Sanofi). Due to persistent and long-term production problems dating back to 2009, some Fabry patients are in declining health due to drug rationing, and others are dead.
Besides the so-called march-in petition to the National Institutes of Health filed under the auspices of the Bayh-Dole Act on April 5, 2011, an earlier petition filed in August 2010 was rejected by NIH in December 2010. Despite the strong-sounding language of the Act, no petition for a compulsory license has ever been granted.
Fabrazyme arose out of federally-funded research at Mt. Sinai Medical School, which licensed it to Genzyme. Both were sued in March 2011 by Fabry patients as another possible means to obtain relief from their disease.
There has never been a compulsory license granted in the US, but there is at least some small chance that Fabry sufferers may be the first to win one.
This post is a continuation of my previous post, Compulsory Licensing of Proprietary Drugs.
Ed Silverman has many posts on this subject at his Pharmalot blog.
Genzyme Drugs Contain Bits of Trash
Here's What the Genzyme Consent Decree Says...
Patients Sue Genzyme & Mt. Sinai Over Fabrazyme (contains link to PDF of lawsuit)
Patients Try Again to Break Genzyme Drug Patent (contains link to PDF of petition)
Genzyme Apologizes for Fabrazyme Screwup
Besides the so-called march-in petition to the National Institutes of Health filed under the auspices of the Bayh-Dole Act on April 5, 2011, an earlier petition filed in August 2010 was rejected by NIH in December 2010. Despite the strong-sounding language of the Act, no petition for a compulsory license has ever been granted.
Fabrazyme arose out of federally-funded research at Mt. Sinai Medical School, which licensed it to Genzyme. Both were sued in March 2011 by Fabry patients as another possible means to obtain relief from their disease.
There has never been a compulsory license granted in the US, but there is at least some small chance that Fabry sufferers may be the first to win one.
This post is a continuation of my previous post, Compulsory Licensing of Proprietary Drugs.
Ed Silverman has many posts on this subject at his Pharmalot blog.
Genzyme Drugs Contain Bits of Trash
Here's What the Genzyme Consent Decree Says...
Patients Sue Genzyme & Mt. Sinai Over Fabrazyme (contains link to PDF of lawsuit)
Patients Try Again to Break Genzyme Drug Patent (contains link to PDF of petition)
Genzyme Apologizes for Fabrazyme Screwup
No comments:
Post a Comment