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U.S. Patients Petition FDA to Regulate Genzyme Export of Fabrazyme

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By James DeGiulio -- In December 2009, the Department of Health and Human Services denied a petition filed by U.S. Fabry patients to secure higher quantities of drug Fabrazyme, exercise Bayh-Dole march-in rights against Genzyme, and issue an open license to U.S. patents needed to manufacture the drug (see "HHS Denies Request to Exercise Bayh-Dole "March-in" Rights for Fabrazyme"). Instead, the FDA entered a consent decree with Genzyme, which gave the FDA authority to regulate distribution of drugs during a shortage, which is the current status of Fabrazyme. Still faced with the prospect of inadequate treatment options, according to a...

Full post as published by Patent Docs on January 26, 2011 (boomark / email).