To reduce the threat to patients posed by unapproved, counterfeit, or otherwise unsafe prescription drugs, the FDA has issued letters to doctors who may have obtained these drugs from a rogue distributor. In addition to warning about the rogue distributors, the letters also contain tips on how doctors can avoid purchasing drugs that: (1) are fake, contaminated, ineffective, or otherwise unsafe; (2) have not been approved as safe and effective by the FDA; (3) do not contain the appropriate amount of active ingredients; (4) contain harmful ingredients; (5) were not manufactured using quality manufacturing processes; or (6) were stored under improper conditions.
- On April 1, 2015, the FDA sent more than 300 letters to medical practices that may have purchased unapproved prescription drugs, or unapproved injectable devices, from a foreign supplier, Gallant Pharmaceutical International, Inc., also known as Gallant Medical International, Inc.
- On July 11, 2013, the FDA sent approximately 250 letters to medical practices that purchased Botox® from “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” The medication’s outer carton was counterfeit, while the vial inside was labeled as a foreign version of Botox.
- On May 13, 2013, the FDA sent more than 1,000 letters to medical practices that may have received prescription drugs from Pharmalogical, Inc., d/b/a Medical Device King, that contained a counterfeit version of Altuzan (bevacizumab) that had no active ingredient. Bevacizumab is approved in the U.S. as Avastin®, and sold by Genentech, Inc.
Many of the distributors of these unsafe drugs have had criminal actions brought against them.
Ilisa Bernstein, Pharm.D., J.D., Deputy Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance, says she has seen a “growing trend of health care professionals and medical practice administrators who purchase prescription drugs from rogue wholesale drug distributors outside of the legitimate supply chain.” Bernstein offers a number of tips for doctors:
- If an offer sounds too good to be true—it probably is. Deep discounts may indicate that the products are stolen, counterfeit, or unapproved.
- Doctors should ensure they are receiving FDA-approved prescription drugs.
- Only purchase from state-licensed wholesale drug distributors.
- Check to see if the packaging, labeling, warnings, and dosing recommendations differ in any way from the FDA-approved packaging, labeling, warnings, and dosing for the product.
- If several patients report that they are experiencing a new side effect or lack of therapeutic effect from the same product, consider that the drug may be substandard or counterfeit.
New tracing, verification, and identification system
The FDA is also working with prescription drug manufacturers, wholesale distributors, repackagers, and dispensers to establish and implement a new system that allows product tracing, verification, and identification as drugs travel through the U.S. market. This effort is part of FDA’s implementation of the Drug Supply Chain Security Act (DSCSA)—Title II of the Drug Quality and Security Act signed into law on November 27, 2013. Under the DSCSA, doctors who dispense or administer prescription drugs are required to purchase their prescription drugs only from authorized trading partners licensed by or registered with the state or federal government.