Full Comment Letter: FDA-2019-ND5711

Submitted March 3, 2020

Docket No. FDA-2019-ND5711 for Importation of Prescription Drugs; Request for Comments

The Campaign for Personal Prescription Importation (CPPI) is pleased to submit comments to the Food and Drug Administration (FDA) regarding its Notice of Proposed Rulemaking to allow importation of certain prescription drugs from Canada.

CPPI is a national nonprofit patient advocacy organization that fights for Americans’ access to safe, affordable prescription medications from Canada for personal use. Tens of millions of Americans – especially the elderly and others on fixed incomes – struggle to pay the extremely high price of prescription medications in the U.S. In fact, our community includes more than 63,000 people who support personal prescription importation. We are here to be their voice.

According to a 2013 Center for Disease Control Survey, approximately 4 million Americans personally import prescription drugs due to cost.[1] These consumers choose from a variety of accessibility options including driving across the border to shop at a bricks and mortar pharmacy to using the Internet to access affordable medicines online. We strongly encourage that any final rulemaking seeking to allow a legal pathway for imported medicines ensure that the millions of Americans already importing safe and affordable prescription drugs from Canada can continue to do so.

Thousands of Americans use licensed Canadian pharmacies every day to purchase their daily prescription medications at an affordable price. The cost of brand prescription drugs from a Canadian pharmacy are typically 50-80 percent less than those found in American pharmacies. Americans trust Canadian pharmacies as a source for safe, affordable medications in large part because the FDA and its Canadian counterpart (Health Canada) have equivalent standards when it comes to ensuring the safety and efficacy of prescription drugs.

Regulators and lawmakers have created the current environment that permits millions of Americans to import medications for personal use. Personal use is defined as a 90 day or less supply.  FDA’s published guidance allows for discretion on a case-by-case basis concerning Americans’ ability to import prescription drugs for personal use: “FDA personnel may allow entry of shipments when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.”

Congress has repeatedly passed laws to protect Americans who import medicines for personal use.  For example, annual Homeland Security Appropriations legislation has included a provision to protect Americans who import on their person a “personal-use quantity of a prescription drug, not to exceed a 90-day supply” by preventing Customs and Border Protection from seizing their medicines (provided the drug in question is not a controlled substance or a biological product). This protection for personal importation has been Congressionally-mandated and signed into law by the president every year since 2012. The “SUPPORT for Patients and Communities Act” – passed by wide bipartisan margins in 2018 – explicitly created a protection for Americans who import “in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”[2]

We believe that FDA’s proposed rulemaking on drug importation misses a critical opportunity to provide a clear legal pathway for personal importation. Unlike the wholesale importation process outlined in the proposed regulations, recognition of a legal pathway for personal importation would have an immediate impact for Americans. Millions of Americans are already accessing safe and affordable prescription drugs from Canada.

Too many Americans are suffering from an inability to afford their medications. The Commonwealth Fund estimates that 45 million Americans did not fill a prescription in 2016 due to cost.[3]  A 2012 survey of CVS pharmacists found that 62 percent of 2,400 retail pharmacists reported high cost as the top reason patients are not taking their medicines.[4]  Americans have only faced sky-rocketing prescription drug prices since these surveys were taken.

CPPI wants to ensure that personal importation is not negatively affected by the proposed rulemaking on drug importation. For millions of Americans Canadian pharmacies are a life-saving source for safe and affordable medications.

Thank you for your thoughtful consideration of CPPI’s comments. We stand ready to serve as a resource for FDA on the importation of prescription drugs for personal use. Please do not hesitate to contact us with any questions.

[1] Cohen RA, Villarroel MA. Strategies used by adults to reduce their prescription drug costs: United States, 2013. NCHS data brief, no 184. Hyattsville, MD National Center for Health Statistics. See http://www.cdc.gov/nchs/data/databriefs/db184.htm

[2] Public Law No. 115-271.

[3] R. Osborn, D. Squires, M. M. Doty, D.O. Sarnak, and E.C. Schneider, “In New Survey of 11 Countries, U.S. Adults Still Struggle with Access to and Affordability of Health Care,” Health Affairs Web First, Nov. 16,2016

[4] “CVS/Caremark Survey Says Cost is Biggest Barrier to Prescription Adherence,” CVS/Caremark Insights, September 27, 2012. See http://www.prnewswire.com/news-releases/cvs-caremark-survey-pharmacists-say-cost-is-biggest-barrier-to-medication-adherence-171516471.html