For 20 years most Democrats and some Republicans have pushed the idea of allowing Americans to import prescription drugs from other countries, outside of the normal U.S. Food and Drug Administration’s process that seeks to ensure safety in both the manufacturing of drugs and their chain of custody to the point of sale. Most recently, some members of Congress want an importation provision included in the FDA Safety and Landmark Advancements Act, which reauthorizes the 1992 Prescription Drug User Fee Act (PDUFA).
And for just as long the Institute for Policy Innovation (IPI) has been warning that importation is extremely dangerous—now more so than ever.
Yet last summer President Joe Biden issued an executive order promoting drug importation, falsely claiming it would enhance competition.
In his July 9, 2021, “Executive Order on Promoting Competition in the American Economy,” Biden says: “To reduce the cost of covered [prescription drug] products to the American consumer without imposing additional risk to public health and safety, the Commissioner of Food and Drugs shall work with States and Indian Tribes that propose to develop section 804 Importation Programs in accordance with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.”
To be clear, it is impossible for any state, Indian tribe or other entity, including businesses, to import prescription drugs “without imposing additional risk to public health and safety”—even if those drugs are allegedly coming from a perceived safe source like Canada.
That’s because drug counterfeiting is rampant. Just go to the Partnership for Safe Medicine’s website and look at all the news stories documenting counterfeit drugs in every state in the country.
President Trump also pushed state efforts to create importation programs. Florida tried, but the program collapsed—as has every other state importation scheme.
The fact is the United States is facing an opioid crisis. Provisional government data indicate some 108,000 people died from drug overdoses last year, up from 94,000 in 2020.
Dr. Nora Volkow, director of the National Institute on Drug Abuse, recently warned, "These past three years we have seen an increase of contamination of other illicit drugs with fentanyl, be it cocaine, be methamphetamine, and more recently, illicit prescription drugs."
While some illicit opioids are now manufactured in the states, much of it is coming from other countries. For example, the U.S. Attorney’s Office in Oregon announced last March, “U.S. Drug Enforcement Administration (DEA) agents based in Portland began investigating a drug trafficking organization led by Luis Antonio Beltran Arrendondo, 32, of Las Vegas, who was suspected of importing counterfeit oxycodone pills containing fentanyl and heroin from Mexico into California, and transporting it to Oregon and Washington State for distribution.”
And while most of the counterfeit drugs are pills—in part because they are easier to make and transport—counterfeit injectable drugs are also available, and equally if not more dangerous.
When IPI began warning of the safety threat posed by various drug importation schemes, importation proponents shouted, “Show us the bodies!” We replied that the bodies would be coming if importation efforts continued to grow. Tragically, the bodies—many of whom are victims of counterfeit drugs—are everywhere.
June 13, 2022