The Department of Justice, on behalf of the FDA, has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, Inc., its president, and its Director of Corporate Quality. According to the Complaint, the defendants violated the Federal Food, Drug, and Cosmetic Act by manufacturing and distributing unapproved and misbranded drug products.
Under the FDCA, before a company can sell a new drug product to consumers, it must submit and receive approval of a new drug application from the FDA. The purpose of this approval process is to ensure that drugs manufactured and distributed to consumers are safe and effective for their intended uses. Furthermore, the FDA requires all drug labeling have adequate directions for use.
This is the second injunctive case that the government has brought against Sage alleging the distribution of unapproved new drugs. In 2000, the government obtained an injunction against the company banning the manufacture and distribution of two unapproved new drugs. Since that time, FDA inspections revealed that the defendants continued to manufacture and distribute other drug products—including prescription pain relievers, over-the-counter cough and cold remedies, and OTC wound cleansers—without first obtaining the requisite FDA approvals. As a result, the defendants’ products are unapproved new drugs and misbranded drugs under the FDCA, and potentially unsafe and ineffective.
Despite numerous warnings from FDA, the defendants have failed to bring their operations into compliance with the law. The Justice Department will seek a permanent injunction requiring the defendants to cease all receiving, processing, manufacturing, preparing, packaging, labeling, holding, and distributing activities until they comply with applicable FDA regulations.
See the DOJ Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication