Health Plans Bemoan Asacol Monkey Business

     BOSTON (CN) – Employee medical plans have hammered drugmakers with federal complaints alleging a conspiracy to corner the market for ulcerative colitis medicine.
     The case hinges on Asacol’s removal from the market in 2013, when its patents were set to expire, and replacement by the more-expensive Delzicol and Asacol HD.
     Allergan completed its acquisition of Warner Chilcott in October of that year. Warner Chilcott meanwhile had acquired the blockbuster drug Asacol from Proctor & Gamble a year earlier.
     In separate federal class actions filed on Sept. 21, three employee benefit funds say that Asacol’s removal from the market prevented a generic version of the drug from becoming available, while also making their Delzicola and Asacol HD the only available options on the market for those who suffer from ulcerative colitis.
     Without the competition of a generic drug, Allergen sold about $550 million of Delzicola and Asacol HD in 2014, according to the complaint.
     The Pennsylvania Employee Benefits Trust Fund, the Minnesota Laborers Health and Welfare Fund, and the AFSCME Health and Welfare Fund are the lead plaintiffs in each case.
     The say the monopolization scheme inflated the drug’s price, which in turn has increased thei cost burden.
     Warner Chilcott’s move to reformulate the drug came on the heels of a nonbinding recommendation from the U.S. Food and Drug Administration to remove dibutyl phthalate (DBP) from the pill, as a means of reducing the risk the drug poses to pregnant consumers.
     Warner Chilcott allegedly used this nonbinding recommendation as a pretense to present Delzicol as a safer option.
     “Several facts, both before and after the introduction of Delzicol, establish that Delzicol is not actually superior to Asacol (400mg) and was introduced purely to game state and federal law, not to improve patient safety,” the complaint states.
     If Warner Chilcott were legitimately concerned with the safety of their customers, it would have switched the formula when concerns about DBP first emerged in the late 1990s, the plans say.
     The company also would not have continued to sell the version with DBP in Canada, according to the complaint.
     Asacol is the brand name for mesalamine, which is used to treat ulcerative colitis, a digestive condition that causes swelling and sores in the lining of the colon, according to the U.S. National Library of Medicine.
     The original formula for Asacol included the inactive substance DBP in the pill’s coating, according to application to the Food and Drug Administrative for a new formula for the drug from Warner Chilcott.
     Although DBP is inert, increased exposure to the chemical has been linked to an increased risk of “developmental and reproductive toxicity.” A person taking the maximum recommended dosage of Asacol, which is six pills a day, would be exposed to three times the amount of DBP than is recommended by the Environmental Protection Agency, according to the FDA application.
     The reformulated Delzicol is similar to Asacol, except that the DBP has been replaced with dibutyl sebacate, and the pill has been placed inside of a dissolving capsule.
     “Warner Chilcott included the cellulose capsule to give Delzicol additional patent protection and to manipulate the regulatory system, not for any legitimate medical reason,” the complaint states.
     Representatives for Allergen have not responded to a request for comment.
     Nathaniel Orenstein with Berman DeValerio filed all three lawsuits Monday.
     He also filed an earlier class action against the drugmakers on Aug. 20, on behalf of the Wisconsin Masons’ Health Care Fund.

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