FDA Warns Online Pharmacy for Selling Drugs That Require a REMS
The FDA sent a warning letter to Global Pharmacy Plus, an internet pharmacy, concerning the company’s marketing of generic versions of the immunosuppressant drugs mycophenolate mofetil and tacrolimus, both of which carry Black Box warnings and must only be distributed under an approved Risk Evaluation and Mitigation Strategy (REMS).
Mycophenolate is dispensed subject to a REMS program that requires healthcare providers to report pregnancies to a registry and includes an educational component regarding fetal toxicity.
The company was offering 500 mg mycophenolate mofetil as “CellCept 500mg” tablets, the letter said. “While there are FDA-approved versions of mycophenolate mofetil tablets, including CellCept, on the market in the U.S., there are no approved drug applications … for the ‘CellCept 500mg’ tablets.”
Global Pharmacy was also offering tacrolimus, listed as “Tacrolimus Capsules Tacrograf – 0.5,” about which the FDA said, “While there are FDA-approved versions of tacrolimus on the market in the U.S., there are no approved drug applications … for ‘Tacrolimus Capsules Tacrograf – 0.5.’”
“We advise you to review your website, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the [Food, Drug and Cosmetic Act],” the agency said.