Today, 1 in 10 medicines worldwide and up to 50 percent of drugs consumed in developing nations are counterfeit. Importation proposals would open the U.S. borders to these dangerous and potentially deadly substances. We support efforts to ensure patients have access to the medicines they need, but importation schemes have not only failed to demonstrate any savings to patients, but the importation of unapproved, potentially counterfeit, substances from foreign countries also poses very real threats to Americans’ health and safety.
For one, there are far too many websites already pushing counterfeits to patients, and drug importation proposals would only encourage more criminal organizations to profit from fake medicines. In 2018, more than 3,600 websites were caught by INTERPOL and the U.S. Food and Drug Administration (FDA) selling illicit and counterfeit medicines. In the summer of 2018 alone, the FDA sent warning letters to more than 70 websites known to be illegally selling unapproved or fake versions of opioids. In just one week in 2018, INTERPOL’s Operation Pangea XI resulted in the seizure of 500 tons of illicit and counterfeit medicines, including anti-inflammatory medication, painkillers, erectile dysfunction pills and medicines to treat serious disease like HIV, diabetes and Parkinson’s – totaling $14 million worth of potentially dangerous pharmaceuticals. And supposedly safe online pharmacies are anything but: In the United States alone, 94.8 percent internet of drug outlets were found to be operating out of compliance with federal and state pharmacy laws and practice standards in 2018.
Clearly, the data show the dangers of exposing Americans to counterfeit medicines through drug importation. The media have reported story after story of Americans put in harm’s way by importation, many losing their lives. That’s why no Secretary of the Department of Health and Human Services (HHS) has ever certified to allow importation from Canada, even though they have had the authority to do so since 2003. Former Secretaries have said they were unable to ensure that drug importation proposals would not pose additional risk to public health and safety and could not certify such proposals would generate cost savings for American consumers. Four former FDA Commissioners recently asserted that even if there were minimal potential savings, it is unlikely they would be passed on to patients. The hypothetical potential for savings is outweighed by the dangers that would face patients. Instead, policymakers should focus on policies to increase price competition through generic and biosimilar entry--speeding the approval of generics, for example, saved Americans $265 billion in 2017 alone.
And while some proponents of importation point to Canada as a safe source for drugs, they fail to acknowledge the facts. Canada has said that it cannot and would not be able to certify that medicines shipped through Canada to the United States are safe. And there have been questions raised about Canada' medicine supply and whether it could support the U.S. population on top of the Canadian population. Just this week, Steve Morgan, a Canadian health economist, told POLITICO that "The Canadian shelves would run dry" under some of the proposals.
Let’s take a good, hard look at the facts. Importation is dangerous, would save patients very little if anything and both the U.S. government and Canadian government have sounded the alarm over such proposals in the past. It’s time for policymakers to acknowledge that this proposal won’t help patients.
To learn more about the dangers of drug importation, visit PhRMA.org/Importation.
Nicole Longo Nicole is 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.