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Novartis,
one of the world's largest pharmaceutical companies, and Genentech, a major biotech firm, say they've uncovered a "dangerous scheme" to import their allergy medication from Canada into the U.S. in violation of U.S. Food and Drug Administration regulations.
Both are suing SHARx — a so-called alternative funding program — and a Canadian pharmacy over the importation of Xolair, an injectable prescription medication for patients with severe asthma, food allergies and respiratory conditions, to an allergy and asthma center in Michigan.
"Biological medicines, like the U.S. Xolair medicine, require particular care because their complex composition and sensitivity to variation in storage and handling conditions are susceptible to contamination and degradation that could undermine their safety and efficacy," according to the lawsuit, filed on Feb. 2 in U.S. District Court in Michigan.
