A New Mexico doctor has pleaded guilty to a federal misdemeanor charge for ordering an unapproved chemotherapy drug from a Canadian supplier and providing it to patients.
According to the FDA, Dr. Mohamed Basel Aswad was charged him with the unlawful introduction of misbranded drugs into interstate commerce. Under the Food, Drug, and Cosmetic Act (FDCA), a prescription drug is “misbranded” if it is manufactured in an establishment not registered with the FDA for commercial distribution within the U.S. or if the drug labeling bears inadequate directions for use.
In March 2012, the doctor ordered Altuzan that did not bear adequate directions for use because the packaging inserts were in Turkish. Dr. Aswad acknowledged that the Altuzan was came from a foreign company not registered by the FDA.
In his guilty plea, the doctor admitted that his sale of misbranded drugs amounted to approximately $1,298,543 in proceeds.
Earlier this year, the FDA’s Office of Criminal Investigations coordinated a complex international investigation that led to the arrest of the owner of Ozay Pharmaceuticals for being the source of Altuzan, the Turkish version of the cancer treatment drug Avastin.
Read the FDA press release