The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and both its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction. The executives are banned from manufacturing and distributing drug products until they bring their manufacturing operations into legal compliance and obtain FDA approval for their products. It was found that Scientific Laboratories manufactures and distributes unapproved and unadulterated drugs.
Scientific Laboratories is a contract manufacturer and distributor of a number of prescription cough and cold products. The government’s complaint—which was filed by the U.S. Department of Justice—alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current Good Manufacturing Practice requirements (CGMP). “The FDA will not allow a company to put the public’s health at risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.” The FDA had previously warned Scientific Laboratories against violating the FD&C Act and also warned it about the risk of enforcement action if corrective measures were not taken.
The consent decree bars the defendants from manufacturing and distributing any drug until FDA approval is received and they are found to be in full compliance with CGMP requirements. The defendants have also been mandated to destroy their illegal drugs. The consent decree allows the FDA to order the defendants to shut down in the event of future violations and subjects the defendants to liquidate damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, as well as an additional sum of $5,000 per violation, up to $1 million annually.
The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, Nazarin HC Liquid
Because these drugs did not undergo FDA review and did not receive FDA approval, their safety and effectiveness have not been established. Also, the FDA has not reviewed the adequacy and accuracy of the product directions and warnings stated in the labeling. “The FDA will take action against companies and their executives who violate the law and endanger public health,” said Margaret O’K. Glavin, associate commissioner for Regulatory Affairs. “The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs.”
If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.
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