Jan 16 (Reuters) - The U.S. Food and Drug Administration has issued a warning letter to Imprimis Pharmaceuticals Inc accusing it of making false or misleading claims that its compounded eye medications had the agency’s approval.
The Dec. 21 letter to San Diego-based Imprimis was posted on the FDA’s website on Tuesday. Imprimis is contesting a lawsuit by rival Allergan Plc over allegations it is illegally selling and advertising unapproved drugs.
The FDA’s letter focused on “Dropless Therapy,” “LessDrops, “Simple Drops” and “Klarity C-Drops,” used in connection with eye surgery made by Imprimis compounding pharmacies that do not make FDA-approved drugs.
The FDA’s letter said that Imprimis’s website violated the Federal Food, Drug and Cosmetic Act by claiming “Simple Drops” and “Klarity C-Drops” were made with FDA approved components.
It also said Impris’s website omitted important risk information including side effects about three of those brands.
The FDA told Imprimis it should take prompt action to correct the violations and that failure to do so could result in legal action.
Imprimis had no immediate comment. Its stock closed at $1.62 on Tuesday, down 12.43 percent.
Traditionally, pharmacists who compounded medications mixed tailored doses for individual patients in response to a specific prescription. Because they were made for specific patients, they were exempted from normal FDA drug-approval requirements.
After a fungal meningitis outbreak linked to a Massachusetts compounding pharmacy called New England Compounding Center that killed 76 people, Congress in 2013 passed a law aimed at giving the FDA greater oversight.
The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk without prescriptions for individual patients while following federal manufacturing standards.
In September, Allergan sued Imprimis, saying it misrepresented the lawfulness of its business and effectiveness of its ocular surgery treatments. Imprimis said Allergan’s lawsuit is aimed at stifling competition.
Allergan said that while Imprimis claimed its drugs were exempt from FDA approval, the company’s mass-manufacturing and marketing of millions of units of was not permissible for a traditional compounder.
While outsourcing facilities may in some circumstances mass produce drugs, Allergan said Imprimis was also flouting those requirements by misusing a narrow exception from obtaining approval to make copies of approved drugs.
The lawsuit contended many of Imprimis’ drugs were essentially copies of commercially available drugs, including a cheaper alternative to Allergan’s FDA-approved dry eye drug, Restasis. (Reporting by Nate Raymond in Boston; editing by Grant McCool)
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