Washington (January 11, 2019) – In response to yesterday’s announcement by Sen. Bernie Sanders, Reps. Elijah Cummings, Ro Khanna, Peter Welch, Joe Neguse, and other cosponsors in the House and Senate The Affordable and Safe Prescription Drug Importation Act (S.97) (H.R.447) and introduction of the Safe and Affordable Drugs from Canada Act of 2019 (S.61) from Senators Chuck Grassley (R-IA) and Amy Klobuchar (D-MN), the Alliance for Safe Online Pharmacies (ASOP Global), issued the following statement:

ASOP Global has significant concerns about the risks of prescription drug importation and the dangers posed by counterfeit medicines. While we appreciate Congressional efforts to find ways to increase patient access to safe, affordable prescription medicines, we strongly believe serious public health risks remain for American consumers that choose to purchase prescription drugs from foreign online sources. Simply put, drug importation puts the health of Americans in foreign hands by undermining the safety and security of U.S. supply chains, it doesn’t save patients money, and it doesn’t work. The healthcare and law enforcement communities oppose it, past importation schemes in states like Illinois, Maine, Minnesota and Vermont have failed and there are better ways available right now for patients to save money on their medications and stay safe.

Drug counterfeiters are driven by simple economics. They make and market the highest cost, hardest to get, and most sought-after drugs to meet American demand. Not only does this include the drugs that fuel the national opioid epidemic that kills an average of 91 Americans per day, but everything from inexpensive generic products for the management of chronic conditions to higher-priced, innovator or breakthrough medicines for cancer and other life-threatening diseases. Counterfeits are often made in unsafe conditions; contain too much, too little, no active ingredients, or one not indicated on the label; and/or may contain dangerous or deadly substances. Most of these counterfeit drugs come from foreign countries like China and India – where drug manufacturing quality controls are much weaker.

All recent former HHS Secretaries and USFDA Commissioners – Republican and Democrat – for the past two decades has said that they can’t guarantee the safety of imported drugs and have warned that these medications can pose serious health risks to patients. Today, there is no federal agency charged with – or even capable of – providing the requisite oversight and safety enforcement over drugs purchased from foreign drug supplies. Further, studies – including an examination by the Congressional Budget Office and a recent report to the Vermont state legislature – estimate that any cost-savings from importation are minimal and not guaranteed to be passed on to patients.

Even without allowing drug importation, the U.S. is already struggling to cope with the influx of foreign drugs on two major fronts: online and through the mail. The internet is awash with illegal online pharmacies posing as “Canadian” and claiming to be selling safe FDA or Health Canada approved medicines.  At any given time, there are up to 35,000 active online pharmacy websites operating on the open web, of which about 96% are operating out of compliance with state and federal law and relevant pharmacy practice standards.[i] U.S. consumers buying medications from alleged ‘Canadian online pharmacies’ rarely, if ever, receive the same regulator-approved products provided to Canadian consumers. Indeed, FDA has found that 85% of the drugs being promoted as “Canadian” came from 27 other countries around the globe. Major loopholes in the U.S. Postal System allow mass quantities of counterfeit pills laced with deadly fentanyl and other synthetic opioids from foreign sources to slip into the U.S. illegally through International Mail Facilities (IMFs). If Congress authorizes drug importation, the inevitable increased volume of drugs from other countries would stress an already overburdened safety system, for which FDA Commissioner Scott Gottlieb recently noted that IMF officials are able to only screen 0.06% of what is believed to be pharmaceutical products entering the country via mail.[ii]

Resources currently exist that can help American consumers stay safe and save money. The National Association of Boards of Pharmacy (NABP)’s .Pharmacy Verified Websites Program helps patients find safe and legal online pharmacies and LegitScript’s Website Verification Tool helps confirm website legitimacy, for example, and prescription discount and price-transparency services like GoodRx.pharmacy, RefillWise.pharmacy, and NeedyMeds.org. Additional cost-saving resources and information about the dangers of drug importation, so-called Canadian online pharmacies, and facts on drug counterfeiting is available for consumers at https://buysaferx.pharmacy/buying-medicine/.

While ASOP Global applauds Congress’ desire to increase patient access to safe, affordable medicines, importation isn’t the answer. ASOP Global welcomes the opportunity to provide data and insights to Congress into why importation is not the solution and offer alternatives for keeping Americans safe.

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ABOUT ASOP GLOBAL

The Alliance for Safe Online Pharmacies (ASOP Global), a 501(c)(4) non-profit organization headquartered in Washington, D.C. with activities in U.S., Canada, Europe, India, Latin America and Asia, is dedicated to protecting consumers around the world, ensuring safe access to medications, and combating illegal online drug sellers. ASOP Global has an expansive membership including non-profit pubic health organizations, international members, pharmacy members, as well as pharmaceutical manufacturers.

[i] Proposed Legislation Brings Risk of Imported Counterfeit Medications, Bypasses Regulatory Safeguards. National Association of Boards of Pharmacy. August 2017. https://nabp.pharmacy/wp-content/uploads/2016/07/Innovations-August-2017.pdf

[ii] https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm611996.htm