Genzyme metabolic news
Two Fabry's disease patients sent a Citizen's Petition to FDA seeking to prevent overseas shipments of Genzyme's Fabrazyme agalsidase alfa until all U.S. patients receive full doses of the drug. The petition said that 62% of the drug manufactured in the U.S. is shipped overseas. In the U.S., where supplies of Fabrazyme have been limited since a vesivirus infection temporarily shut down the plant where it is made in 2009, no newly diagnosed patients are eligible for treatment and preexisting patients are rationed to less than half of the recommended dosage, according to the petition.
The petition said denying the drug to U.S. citizens in favor of non-U.S. citizens violates the Food, Drug and Cosmetic Act and the federal Bayh-Dole Act. Bayh-Dole allows the government to make federally funded inventions available to the public under certain circumstances, including when "action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees." Genzyme declined to comment. ...