Drug company Allergan USA Inc., which makes the $1.4 billion blockbuster dry eye treatment Restasis, can proceed with its claims that Imprimis Pharmaceuticals Inc. is mispresenting the lawfulness of its drug compounding business and the safety and efficacy of its compounded eye drugs.
Allergan’s allegations that San Diego-based Imprimis is misleading consumers and doctors sufficiently state a claim under the Lanham Act, Judge David O. Carter of the U.S. District Court for the Central District of California said Nov. 14. The federal Lanham Act prohibits the use of false or misleading statements or representations of fact in commercial advertising, and establishes a private remedy for any violations.
Allergan’s suit against Imprimis highlights the ongoing controversy over drug compounding, the practice of combining, mixing, or altering an existing drug’s ingredients to create medication specifically tailored for an individual patient’s needs. Compounded drugs are often less expensive than mass-produced branded drugs but there are concerns compounded drugs could put patients at risk.
Compounding received national attention in 2013 after contaminated compounded drugs sold by the now-shuttered New England Compounding Center (NECC) caused a deadly fungal meningitis outbreak.
Allergan’s claims that Imprimis made false statements it was operating lawfully as a compounder under the FDA’s framework for regulating compounding under the Drug Quality and Security Act of 2013, passed in the wake of the NECC tragedy, also passed muster and weren’t precluded, the judge said.
Allergan also has a similar suit pending in the same California federal court against Prescriber’s Choice Inc. and Sincerus Florida LLC over compounded dermatology drugs that compete with Allergan’s acne treatment Aczone.
The case is Allergan USA Inc. v. Imprimis Pharmaceuticals Inc., C.D. Cal., No. 8:17-cv-01551-DOC-JDE, order 11/14/17.
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