US FDA slams 13 firms for selling unapproved drugs online
The letters were sent on September 19 from the FDA’s Center for Drug Evaluation and Research (CDER) to the following 13 web-based companies, calling on them to “cease marketing violative drug products to US consumers:”
247Med, PharmCash, GlavMed, Worldwide Drug Store, Medicina Mexico, Rx-Partners, Bulk2USA, CanAmerica Global, American Pharmacy Group, MediPK, Pharmempire, HA Stores Ltd, and MyRXCash.
Within each letter, the FDA gives examples of unapproved new drugs available for US consumers to buy, with seven of the companies offering consumers oral chloramphenicol. The product is an antibiotic useful for the treatment of a number of bacterial infections, but the product has been unavailable in the US in an oral formulation since 1991 because of associated cases of aplastic anaemia.
One of the firms cited, Medicina Mexico which claims to be licensed and regulated by the Mexican Government, acknowledged the letter on its website.
“The medicine that Medicina Mexico sells online are ‘sold over the counter’ in Mexico. HOWEVER, The United States requires a prescription for these medications,” the firm posted on its website. “Consequently, our Mexican MD’s will be issuing prescriptions to our customers.”
However it added: “All customers residing in the US will be prohibited from purchasing medications from Medicina Mexico that are not currently approved by the United States Food and Drug Administration.”
Auvi-Q and opioids
Another product cited in the letter to Canada-based online pharmacy CanAmerica Global was the availability of Sanofi’s injectable epinephrine Allerject. It was marketed in the US under the name Auvi-Q but suspected device malfunctions in 2015 led to production being halted and Sanofi pulling the product the following year, handing the rights back to partner Kaléo.
The FDA also cited examples of opioid-based unapproved and misbranded products available for sale, including formulations of tramadol, hydrocodone, and codeine and ibuprofen.
The Agency noted the availability of such products is “particularly concerning given their potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the US.”
According to the FDA, deaths involving prescription opioids have quadrupled since 1999, and in 2015, opioids were involved in the deaths of 33,091 people.