In May, the FDA sent U.S. marshals into a warehouse to seize $11 million worth of drugs, everything from ear drops to urea cream, from an Indian company that the agency said were unapproved. Now the company is going to have to destroy them all while the FDA watches.
A U.S. district judge signed off on a permanent injunction against Ascend Laboratories, a subsidiary of Indian drugmaker Alkem Laboratories, the FDA said this week. It bans Ascend, and anyone associated with the company, from manufacturing and distributing any drugs until it gets them approved by the FDA.
The FDA started its action after an inspection last November, in which it determined Ascend was selling these products and had never put the through the regulatory process to see if they were formulated and manufactured to standards. The FDA seized the drugs at a warehouse in Cincinnati, OH. The order requires Ascend to post a bond to retrieve the products and then requires that the company destroy them under FDA supervision.
"Manufacturing and distributing unapproved prescription drugs puts patients' health at risk since they have not been found to be safe, effective or made using quality manufacturing practices," Ilisa Bernstein, acting director of the FDA's office of compliance said in a statement. "Companies that fall short of our requirements risk FDA action to stop the distribution of their products."
The FDA has taken out after other companies that advertise and sell products as treating conditions but which have yet to be approved. In 2012, it had marshals quarantine products at Global Biotechnologies of Portland, ME, because it said claims it made that products can cure diseases violated federal law.
- here's the FDA announcement