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June 25, 2013 / Scott Tillett

U.S. Government Sues Pharmaceutical Company for Distribution of Unapproved and Misbranded Drugs

The Department of Justice (“DOJ”) has filed a lawsuit, on behalf of the Food and Drug Administration (“FDA”), against Sage Pharmaceuticals, Inc. (“Sage”) in the U.S. District Court for the Western District of Louisiana. The complaint alleges that Sage violated the Federal Food, Drug, and Cosmetic Act (“FDCA”) by manufacturing and distributing drugs that had not been approved by the FDA.

The FDA is charged with approving all drugs sold in the United States to ensure that they are safe and effective for use by consumers. Assistant Attorney General Stuart Delery commented that “those companies that undermine [the FDA’s] mission will be held accountable.”

This is not the first time that Sage has been under government scrutiny for the sale of unapproved drugs. In April 2000, the government obtained an injunction against Sage banning the sale of two unapproved cold and allergy medications, Palgic D and Palgic DS. As a result, Sage has been the subject of continued monitoring and FDA inspections, which now reveal that the company continues to distribute unapproved pain relievers and over-the-counter cold medications without first obtaining FDA approval.

Despite several warnings from the FDA, Sage has failed to comply with approval requirements for the sale and distribution of new drugs. The DOJ and the U.S. Attorney’s Office now seek a permanent injunction requiring Sage to cease the manufacturing, sale, and distribution of all pharmaceutical products until it has brought its operations into line with FDA regulations.

If you or someone you know has purchased drug products that have not been approved by the FDA, you may be entitled to relief. Please call Khorrami Boucher Sumner Sanguinetti, LLP for a confidential consultation.


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