Novartis Must Face Claims It Promoted Drug for Off-Label Uses

novartis_off_label_useA federal judge ruled that Novartis Pharmaceuticals must face claims that it promoted use of the drug Elidel (pimecrolimus) for infants, although U.S. regulators had deemed it harmful to those younger than age 2.

Donald Galmines, while employed as a senior sales consultant for Novartis, marketed and sold the atopic dermatitis drug, Courthouse News Service reports. The U.S. Food and Drug Administration (FDA) approved Elidel as a second-line treatment for atopic dermatitis—a form of eczema—in patients age 2 and older.  The agency amended the drug’s safety warnings after it found that Elidel posed risks to infants.

Galmines said Novartis continued marketing Elidel as safe for children under the age of 2 and as a first-line treatment, even after the FDA revealed in 2005 that the drug increased the risk of cancer in animals and respiratory infections in children younger than 2, according to Courthouse News Service. Galmines said Novartis trained him and paid Dr. Lawrence Eichenfield, a pediatric dermatologist, to convince doctors to prescribe Elidel for infants. Galmines said Novartis created materials for sales reps to use to engage in off-label marketing of the drug and, he said, the company had him buy expensive dinners for doctors who frequently prescribed Elidel.

U.S. District Judge Gene Pratter, in allowing some of the claims to go forward, wrote that “Mr. Galmines has sufficiently plead that false claims for Elidel prescription reimbursements were submitted to the government,” according to Courthouse News Service. Pratter wrote that Galmines “injected precision into his off-label marketing allegations by pleading a myriad of details about how such marketing occurred.” While doctors are allowed to prescribe drugs for off-label uses, drug companies are not permitted to market a drug to doctors except for FDA-approved uses.

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