Personal Not Wholesale Importation Delivers the Savings Patients Need
WASHINGTON, D.C. – The Campaign for Personal Prescription Importation (CPPI), which has advocated for Americans’ access to affordable prescription medications via importation for over a decade, warns that “Colorado’s drug importation plan could jeopardize genuine U.S. patient access.” On December 5th, 2022, the Colorado Department of Health Care Policy & Financing announced the submission of its Section 804 Importation Program (SIP) application to the federal Food and Drug Administration (FDA) for federal review and approval.
“Colorado’s Drug Importation proposal could jeopardize genuine prescription medication access for millions of U.S. patients who depend on it. Americans are in dire need of affordable access to critical medications that importation can offer, but wholesale state importation is not the solution,” says Jack Pfeiffer, executive director of CPPI.
The Canadian government has repeatedly warned that it could halt the importation of medications into the U.S. should supplies run low or prices increase for its citizens. Now the list of drugs that Colorado is proposing to import includes several that are specialized drugs available in limited quantities or already in short supply in Canada. CPPI warns that it is highly unlikely that drugmakers would increase supply for importation into the U.S. and are more likely to block deliveries to Coloradans.
Since 2017, state legislatures across the country have taken over 120 legislative actions to try to reign in high drug costs. Efforts aimed at importation programs have taken hold in six states. There is opposition to the wholesale importation pathway these states are pursuing because it would not deliver the full savings to patients, instead, programs would layer in new middlemen.
None of the State Importation Programs have been enacted as of yet. U.S. and Canadian regulatory restrictions, as well as legal challenges, remain obstacles for these state pursuits.
Individual Americans importing prescription drugs for personal use report saving 36% more in 2021 than in 2020, in survey results from the Campaign for Personal Prescription Importation. Average annual savings increased by over $1,000 to $3,744 per person in 2021, up from $2,736 in 2020, through purchases from licensed Canadian pharmacies compared to costs in the U.S. Those substantial savings offered to millions of Americans through importation could be put in jeopardy under state wholesale plans.
The state wholesale importation plans are laden with extensive requirements that add layers of bureaucracy, which would take years to implement. Moreover, there is extensive opposition to State and tribal wholesale importation programs. Canadian regulatory restrictions, federal approval, and legal challenges remain obstacles for state wholesale importation programs to become operational. CPPI warns that wholesale/state importation plans could have the unintended consequence of cutting Americans off from the licensed pharmacies on which they depend.
Background:
Colorado
The Colorado Department of Health Care Policy & Financing Section 804 Importation Program (SIP) application to the FDA will receive at least a six month SIP review timeline. The Department estimates that the Colorado Importation Program will be operational by mid-2023, at the earliest. Colorado’s SB19-005, signed into law in May 2019, created a “Canadian Prescription Drug Importation Program” in the Department of Health Care Policy and Financing (CHCPF).
Florida
Florida enacted its importation bill, SB19, in June 2019 and submitted the Florida State Import Proposal to HHS in July. Under the Florida plan, the state will purchase drugs for state agencies (including for the Medicaid program and the corrections and health departments) and it is projected to save the state between $80 and $150 million in the first year alone. Florida Governor Ron DeSantis included $15 million in his proposed 2021-2022 budget for an importation program and has contracted with LifeScience to lead the proposed implementation.
Maine Maine signed LD1272 into law in June 2019 and submitted an application to HHS in April 2020. Maine’s bill allows the state to consider whether the program may be developed on a multistate basis through collaboration with other states.
New Hampshire
New Hampshire’s drug importation law, which was enacted in July 2020, stated that the state would submit a plan to HHS by February 1, 2021.
New Mexico
New Mexico’s governor signed SB1, in March 2020. New Mexico’s plan would authorize the state to create a wholesale prescription drug importation program administered by New Mexico’s Department of Health. PHARMA has contested New Mexico’s new law in court.
Vermont
Vermont’s governor signed S 175, in May 2018, which directed the Agency of Human Services (VAHS) to design a program for wholesale Canadian prescription drug importation. In October 2019, the governor submitted a concept plan to HHS.