The Justice Department has filed a lawsuit against a Louisiana pharmaceutical company to stop the sale of drugs that the Food and Drug Administration (FDA) says are labeled incorrectly and have not received federal clearance to be marketed in the United States.
Sage Pharmaceuticals, based in Shreveport, has been making and selling prescription painkillers and over-the-counter cold medicines and wound cleansers without FDA approval. The agency says it has been repeatedly warning the company to stop illegally making and distributing the products.
In 2000, the government filed an injunction against Sage Pharmaceuticals, to prevent the company from selling two unapproved drugs. The current lawsuit aims for a permanent injunction that would cease all drug-making operations at the facility until it complies with federal guidelines.
Typically, companies that wish to market a prescription drug in the United States must first submit to the FDA a new drug application. It is the responsibility of the drug company to test the drug and submit evidence that it is safe and effective. A team of physicians, statisticians, chemists, pharmacologists and other scientists reviews the company’s application and proposed labeling and advises the FDA on whether safety and efficacy of the drug makes it a good candidate for treating a certain condition. The FDA is not required to follow the recommendation of its advisory committees, but it usually does.
Over-the-counter products do not have to go through such a rigorous process as prescription drugs; however, there are parameters the product must meet before the FDA will grant approval.
Drugs that don’t meet these criteria are not legally marketed and the drug company that distributes them can face fines and penalties.