The U.S. Department of Justice (DOJ) announced the sentencing of a Tijuana man who smuggled non U.S. Food and Drug Administration (FDA)-approved pharmaceuticals into the country and sold those along with counterfeit erectile dysfunction drugs to residents in San Diego County. Alejandro Hernandez, 54, will spend 30 months in federal prison and has also been ordered to pay almost $10,000 in restitution. Over the course of what was a long-term undercover investigation, agents purchased the counterfeit and non FDA-approved pharmaceuticals from Hernandez six times.
The drugs Hernandez sold to agents included Buscapina, Prodolina, Neo-Melubrina, Viagra, and Cialis. The FDA banned the sale of Neo-Melubrina in 1977 because of potentially fatal side effects, but that has not stopped people from bringing it over the border. In 1999, an 18-month-old girl in California died after being injected with the drug. Surveillance revealed that Hernandez stored the illegal pharmaceuticals in multiple self-storage units near the border. A search of just one unit turned up over $250,000 of unapproved and counterfeit pharmaceuticals, as well as ledgers documenting sales going back years.
At the conclusion of this case, U.S. Attorney Adam L. Braverman said, “This office is committed to protecting the health and safety of the citizens in our district by keeping counterfeit and unapproved prescription drugs off the market, and prosecuting individuals who seek to profit from the illegal distribution of such drugs.” FDA Office of Criminal Investigations Special Agent in Charge Lisa Malinowski said, “The mission that drives our investigations is protecting patients from unsafe drugs. As there are no assurances that unapproved products from foreign sources are safe or effective, we must protect consumers from these foreign unapproved medicines. The FDA will continue to pursue and bring to justice those who violate the Federal Food Drug and Cosmetic Act by introducing unapproved and misbranded drugs into interstate commerce.”