WASHINGTON - A Columbia drug company and its top executives have agreed to stop making prescription cough and cold products after repeated failures to pass federal inspections and get government approval of the medicines.
Scientific Laboratories Inc. Chief Executive Officer Amit Roy and President Rajeshwari Patel signed a consent decree in U.S. District Court in Baltimore earlier this month. The company had been making various drugs for other pharmaceutical companies, which then sold the products under their own labels.
But the Food and Drug Administration had sought its toughest sanction because the agency had never approved the drugs, and the company had failed inspections as far back as 2005.
"We want to assure that consumers get drugs that are proven safe and effective, and that certainly wasn't the case with these products," said Michael M. Levy, an FDA official who worked on the case.
At the most recent inspection in August, FDA inspectors found that Scientific Laboratories was not following good manufacturing practices such as testing products for microorganisms, according to court papers. Nor did the firm have records indicating manufacturing equipment was being maintained or cleaned.
Scientific Laboratories is required under the consent decree to recall drugs it has sold since Jan. 1, 2007, and destroy them. The company must get FDA permission before it can resume making drugs, even to manufacture over-the-counter products.
"The company is cooperating fully with the FDA and is evaluating its options for future activities," said Philip Katz, a lawyer at Hogan & Hartson who represented Scientific Laboratories.
Located on Old Columbia Road, Scientific Laboratories made drugs called 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, L-All 12 Suspension, Nazarin Liquid and Nazarin HC Liquid, according to court papers.