FDA Warns Doctors of Counterfeit Drug Distributors

Federal health regulators have launched a new information website designed to help educate doctors on the growing dangers associated with counterfeit drugs. 

The FDA’s Know Your Source website gives doctors tips on identifying counterfeit drugs, warning against buying drugs from questionable sources, and providing healthcare providers with a tool to help verify their wholesale drug distributor’s license.

The agency’s focus is on the wholesale distribution network, where it appears counterfeit drugs are most likely to slip into the U.S. market.

“While the U.S. health care supply chain is one of the most secure and sophisticated in the world, there is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market,” the agency warns doctors.

To combat the threat, the FDA has faxed a number of flyers to doctors’ offices nationwide, which is the same way illicit wholesalers often advertise. The agency urges health care professionals to:

• Be wary of sales and deals that are too good to be true
• Look out for unfamiliar packaging, safety information, doses or labels not in English
• Buy from a wholesaler licensed in their state
• Pay close attention to patient feedback of new side effects or lack of therapeutic effects.

Counterfeit Drug Activities Increasing

The new warnings and information come following a number of high profile counterfeit drug incidents in the last several years.

In April 2013, the FDA warned that counterfeit Botox was being sold by unlicensed foreign manufacturers and distributors through a company called Online Botox Pharmacy. The company sent mass faxes to prospective customers.

In May 2012, the agency issued a warning that there were fake Adderall pills in circulation, that did not actually contain the active ingredients, but instead contained tramadol and acetaminophen, which are painkillers that do nothing for the treatment of attention deficit hyperactivity disorders (ADHD) or narcolepsy, which is what Adderall is approved to treat. In addition those taking the pills faced an increased risk of liver damage because they were unaware they were taking acetaminophen.

A counterfeit drug warning was also issued in February 2012 for the cancer drug Avastin. The drug circulating was potentially dangerous and did not contain the active ingredient, bevacizumab. The agency warned at least 19 facilities believed to have purchased the fake drugs that their patients were actually not getting the cancer therapy they thought they were administering.

In February 2013, the Institute of Medicine (IOM) issued a report calling for global efforts to combat the manufacture and sale of low quality and counterfeit drugs. The report was commissioned by the FDA.