George Karavetsos, former head of the U.S. Food and Drug Administration’s Office of Criminal Investigations wrote this editorial for the Miami Herald on May 6, 2017.
There is no doubt that the increasingly globalized nature of trade within the United States and around the globe has opened the door to an expansive number of goods and services for consumers. In fact, the growth of globalization has encouraged some policymakers to suggest that importation of prescription drugs would be a worthwhile opportunity for millions of Americans.
Nothing could be further from the truth. The United States has the safest prescription drug supply distribution chain in the world, but recent Congressional proposals that would allow for the importation of prescription drugs would threaten this vital safety net, undermine the nation’s public health, and put millions of consumers at risk.
Our closed drug distribution supply chain — heralded as the “gold standard” for safety — means that only medications approved by the U.S. Food and Drug Administration (FDA) are distributed to American consumers. FDA-approved drugs have gone through rigorous scientific testing and clinical trials to establish safety and effectiveness, and each step of the prescription drug supply chain — from the manufacturers, to the distributors, to the pharmacists – is highly regulated.
Despite these extensive checks and balances, globalization tests FDA’s regulatory capabilities every day. As a former director of the FDA’s Office of Criminal Investigations, I have seen firsthand an unprecedented level of sophistication from criminal organizations actively engaged and determined to infiltrate our closed drug supply.
During the past four years, criminal organizations posing as legitimate online pharmacies flooded the U.S. drug supply chain with hundreds of millions of dollars in illegal unapproved foreign and counterfeit drugs to treat cancer, HIV, rheumatoid arthritis, high blood pressure, and attention deficit disorder. In each case, the FDA determined that many foreign, unapproved drugs were either manufactured under unsanitary conditions, were not stored properly or kept in temperature controlled environments, did not have the proper labeling to ensure the proper administration of the product, or did not contain the drug’s active ingredient (in some cases no active ingredient) that was listed on the vial or pill bottle’s label.
Those who believe drug importation provides a feasible alternative to our current prescription drug market would effectively shift the burden of protecting the health and safety of U.S. citizens from the FDA and place it in the hands of foreign countries and suppliers. With the added volume of foreign drugs entering the United States, the FDA would not be able to screen and verify the authenticity of every single drug coming to the market.
Even in cases where the FDA was able to detect a counterfeit medication, there would be no way to trace it back to the source. For those patients who are ordering from purported Canadian pharmacies — one of the biggest hoaxes facing the health system today — they are receiving drugs that are shipped from China, India, Pakistan, Turkey, Vietnam, and the United Arab Emirates. That’s because it’s illegal for Canadian pharmacies to sell medications to Americans outside of the Canadian health system.
Congress must ensure that the U.S. drug supply chain remains secure. We must continue to support the vital role that FDA has in fighting against criminal organizations and ensuring millions of Americans continue to benefit from the treatments that they rely on the most.
Passing legislation to allow for a flood of imported, unapproved drugs, would tilt the balance more toward criminal elements, to the grave disadvantage of consumers.