A US judge has refused to dismiss an Allergan lawsuit that claims Imprimis Pharmaceuticals unfairly sells unapproved new drugs under the guise of compounding and engages in false and misleading advertising.
Judge David O. Carter of the US District Court for the Central District of California issued his ruling Nov. 14, finding that the court could proceed without infringing on the FDA’s authority.
Imprimis, which offers proprietary compounded formulations, has defended its business practices and claimed that Allergan has a history of attempting to limit patient choice and drive up the cost of ophthalmic therapies.
Allergan’s complaint accuses Imprimis of violating the Lanham Act, a federal law that prohibits false advertising. Allergan also accuses Imprimis of breaking California’s unfair competition law.
Allergan claims that many of Imprimis’ standardized new drugs are copies of other FDA-approved drugs and that Imprimis skirts the normal regulatory approval process under the guise of being a compounder, giving Imprimis an unfair advantage over traditional pharmaceutical companies, such as Allergan.
“Imprimis purports to avoid the drug-approval requirement by falsely presenting its products as lawfully ‘compounded’ when in fact Imprimis’ products are mass-manufactured standardized formulations of unapproved new drugs that cannot lawfully be sold and that threaten patient safety,” Allergan’s suit claims.
Allergan goes on to argue that Imprimis violated the Lanham Act by advertising that its products are in line with the federal Food Drug and Cosmetic Act (FDCA); Allergan contends the products are not.
In its motion to dismiss, Imprimis said that it is not up to the court to decide whether the company is in line with the FDCA; that matter falls under the FDA’s jurisdiction. Imprimis also said it is not in violation of the FDCA.
Carter disagreed. The judge said the Lanham Act and the FDCA “complement” each other, citing a previous Supreme Court decision—POM Wonderful v. Coca-Cola Co.
“Because Imprimis’ alleged conduct clearly violates the plain text of the statute (FCDA), the question of legality in this case does not implicate the FDA’s rulemaking authority,” Carter wrote.
Carter also agreed with Allergan that the company had standing to sue Imprimis under the Lanham Act because many of Allergan’s drugs, particularly its dry eye drugs, compete with Imprimis’ products and that Allergan did enough in its complaint to show it suffered “an injury” to its reputation and sales.
Imprimis also asked the court to stay the suit until after FDA finalizes rulemaking pertaining to outsourcing facilities. Carter denied that request. He also refused to throw out parts of the lawsuit that state Imprimis unfairly claimed its products were superior.
Attorneys familiar with the case have said it could have a wide-ranging impact on big compounders and the pharmaceutical industry at large, according to a story published by Law360.