A Shreveport, La., pharmaceutical company has been manufacturing and distributing unapproved and misbranded drug products for several years, even though U.S. Food and Drug Administration (FDA) inspectors discovered unlawful business practices within the company 13 years ago.
According to the U.S. Justice Department, Sage Pharmaceuticals Inc. has ignored numerous FDA warnings to bring its drug and wound-treatment products into compliance with U.S. regulations. The U.S. government first obtained an injunction against the company in 2000, banning it from making and selling two new drugs that were never approved by the FDA.
Since that time, however, FDA inspectors found that Sage continued to make and distribute other drug products, including prescription pain killer, over-the-counter (OTC) cough and cold medicines, and OTC wound cleansers, without obtaining the required FDA approvals. The FDA considers the unapproved products to be misbranded under the terms of the federal Food, Drug, and Cosmetic Act (FDCA) and potentially ineffective and unsafe for consumers.
The FDA then referred the case to the U.S. Justice Department, which filed a suit against the company, its president, Dr. Jivn-Ren Chen, and its director of corporate quality, Charles Thomas, in U.S. District Court for the Western District of Louisiana. The suit seeks a permanent injunction against Sage and its officials barring them from all receiving, processing, manufacturing, preparing, packaging, labeling, holding, and distributing activities until they comply with applicable FDA regulations.
Stuart Delery, Acting Assistant Attorney General for the Civil Division, said that the lawsuit “furthers the FDA’s mission of ensuring that all drugs sold to the public are safe and effective, and those companies that undermine this mission will be held accountable.”
He did not address why the company was allowed to make and push unapproved drugs for more than a decade, or whether the FDA and DoJ will seek civil fines against the company or criminal charges against its executives.