US FDA pressure on unapproved drugs

The US Food and Drug Authority has negotiated a consent decree with one drug manufacturer and sent warning letters to four others, in a continuing campaign against the marketing of unapproved drugs. In June this year, the FDA issued a guidance document titled: Marketed Unapproved Drugs - Compliance Policy Guide (Marketletter June 19).

New York-based Syntho Pharmaceuticals and Intermax Pharmaceuticals have signed a consent decree of permanent injunction that bars them from manufacturing or marketing any drugs that do not have the FDA's gold standard approval, or do not meet the agency's Good Manufacturing Requirements.

FDA warning letters for marketing unapproved drugs have been sent to New Jersey-based Neil Laboratories, Concord Laboratories; Maryland-based Scientific Laboratories; and Connecticut-based Sheffield Laboratories. Copies of the FDA warning letters can be found on the agency's web site at: www.fda.gov/foi/warning.htm.