The manufacturing and trafficking of counterfeit drugs is not just a U.S. concern but a growing threat globally. Governments around the world are working together to try to prevent these fake products from reaching and harming patients. While the U.S. market is the most secure with a closed supply chain, there remains the threat of counterfeit and adulterated drugs reaching U.S. patients. This risk increases dramatically if medicines are imported from and travel through other countries before reaching the United States because there would be no way to ensure the safety and efficacy of those products.
In the past, we’ve highlighted one case study looking at the trajectory of developing counterfeit cancer drugs, how the drugs ended up in the United States and how the U.S. Food and Drug Administration rapidly worked to remove the counterfeit medicines from the U.S. market. That is just one example of a counterfeit drug that happened to reach the United States.
There are other examples of counterfeit drugs that have been found abroad that are a good indication of the kinds of counterfeits out there that are a risk to the United States. Take for example the discovery of counterfeit hepatitis C drugs in Israel.
- A counterfeiter in India began developing and selling a fake hepatitis C medicine.
- The counterfeiter then shipped the fake drugs through a Swiss trading company to Israel and Switzerland.
- It was only then that they were discovered and regulators began investigating where the drugs came from. Those regulators are still investigating, hoping to determine if the fake drugs ended up in any other countries.
Since that discovery, fake hepatitis C drugs have been found twice. Authorities in Pakistan raided a factory and discovered an illicit manufacturer in the process of making fake versions of the hepatitis C treatment, and counterfeit versions of the drug have been discovered in a legitimate pharmacy chain in Japan. It is not yet known if these counterfeits were from the same source.
New medicines for hepatitis C have the potential to cure more than 90 percent of treated patients, but not if counterfeit drugs are delivered to patients instead.
It is instances like this that illustrate the risks associated with importation of medicines. Foreign governments, including Canada, have stated they cannot guarantee the safety and efficacy of medicines sent from or through their countries to the United States. Opening U.S. borders to a flood of foreign products that may or may not be what they claim to be threatens the safety and security of our drug distribution system and unnecessarily places patients’ lives at risk.
Learn more about why drug importation is bad for patients here.
Nicole Longo Nicole is senior director of public affairs at PhRMA focusing on Medicare, 340B, importation and more. She previously worked for a D.C.-based public affairs firm where she assisted a wide range of clients with communications efforts on everything from trade policy to agriculture policy to health care policy. Outside the office, Nicole can be found trying new restaurants (usually Italian), taking an occasional barre class and cheering on the Cincinnati Bengals.