Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan,” which would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a huge safety risk and a broad range of stakeholders have expressed their concern about the plan. Drug importation schemes increase the potential for counterfeit or adulterated products to infiltrate the U.S. pharmaceutical supply chain, putting Americans in harm’s way. As PhRMA President and CEO Stephen J. Ubl explained, “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”
Here’s a look at what other stakeholders have said about the proposal:
- “The Action Plan is an unintentional but dangerous launching pad for criminals who make millions peddling fake and unsafe drugs to Americans online. This is a deeply dangerous result for American consumers. Research shows that U.S. consumers buying medications from ‘Canadian online pharmacies’ rarely, if ever, receive Health-Canada approved medicines.” – Alliance for Safe Online Pharmacies, Press Statement, July 31, 2019
- “Americans are rightly concerned about the rising costs of medicines. But as solutions are proposed to address the issue of affordability, importation policies of any kind will have significant implications for the safety and security of the pharmaceutical supply chain and patient health. … [F]ederal proposals to permit prescription drug importation would result in significant costs due to patient risks, additional regulatory oversight and the operational challenges placed on the healthcare supply chain.” – Healthcare Distribution Alliance, Press Statement, July 31, 2019
- “No HHS Secretary or Commissioner of the Food and Drug Administration (FDA) under either party has ever confirmed that importing pharmaceuticals would keep Americans safe from dangerous counterfeit drugs, including the opioids that have caused so much destruction across our country…The HHS proposal would expose Americans to potentially adulterated drugs and encourage unscrupulous actors to get more involved in drug importation. It would hurt U.S. biopharmaceutical research and development.” – Citizens Against Government Waste, Press Statement, July 31, 2019
- “The exploration of drug importation by the Trump Administration would put the health of patients at risk, chill innovation and hurt union construction jobs…PILMA is opposed to importation in all forms and reaffirms its 2017 resolution in opposition to this policy. It would be shortsighted if the administration removed the safeguards put in place over the last 50 years and opened up the U.S. to adulterated drugs while chilling current and future innovation.” – Pharmaceutical Industry Labor Management Association, Press Statement, July 31, 2019
In Canada, there have also been concerns raised with many pointing out how the proposal is unworkable. As Joelle Walker, with the Canadian Pharmacists Association explained to The Washington Post, “This is going to exacerbate some of the drug shortages that we’re already seeing in Canada … . We aren’t equipped to deal with a country that is ten times our size.” And even before the Administration formally announced its proposal, the Canadian Medical Association and 14 other organizations sent a letter to Canada’s Minister of Health, “request[ing] that Health Canada provide clarity and assurances to Canadians that U.S. legislation will not inadvertently disrupt Canada’s pharmaceutical supply and negatively impact patient care through greater drug shortages.”
The FDA is the gold standard for regulating the safety of the U.S. medicine supply. Importation of drugs from other countries outside of the FDA’s regulated, closed supply chain could taint our medicines and have life-threatening consequences for American patients.
Learn more about the dangers of drug importation here.