Laws allowing the importation of wholesale prescription medications provide cost savings to patients but require HHS approval.
On May 16, 2018, Vermont became the first state in the nation to enact a law allowing the importation of wholesale prescription drugs.1
Under this law, Vermont would be able to act as a wholesaler to purchase prescription drugs from Canada. Because prescription drugs in Canada cost an average of 70% less than the same products in the United States, this action would ultimately save the residents of Vermont money by allowing them to purchase certain prescription drugs at lower prices.2
One of the most important aspects of this law is that drugs imported from Canada must meet all current US medication safety requirements.1 The primary concern for health care providers regarding drug importation is patient safety. This is where prescription drug importation programs face the most opposi- tion because it would be extremely difficult to ensure that all drugs coming into the United States are as safe and effective as those manufactured in-country.
The major barrier to Vermont’s new legislation being implemented is that the law requires federal approval from the secretary of the US Department of Health & Human Services (HHS). Federal law prohibits the importation of non—FDA-approved medications into the United States. This includes FDA-approved drugs produced outside the United States as well as drugs produced in the United States that are intended for sale in foreign markets.3 Under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the secretary of the HHS must approve any action to import prescription drugs into the United States.4 Before the secretary can approve such a request, he or she must ensure that the medications to be imported are effective and safe for patients. To date, the secretary of the HHS has never granted permission to any of the requests to import prescription drugs into the United States.
In late July, President Donald J. Trump, along with HHS Secretary Alex Azar, requested that the FDA create a task force to investigate the safety and logistics of importing prescription drugs into the United States.5 The goal was to examine the possibility of importing prescription drugs that have had big price increases or that patients have had challenges accessing. Within these categories, the prescription drugs being considered for importation are only those that have just 1 manufacturer in the United States and are off patent. Therefore, only a select few drugs that fit these profiles will even be considered for importation, and the FDA must be able to ensure the effectiveness and safety of these drugs as well.
Although the long-term implications of this task force for prescription drug importation are unknown, its creation does strongly suggest that importation is something the federal government is seriously considering. The hope is that the importation of these drugs will increase competition in the United States, resulting in lower drug prices for patients.
Vermont is not the only state proposing wholesale drug importation programs as a solution to rising drug prices. Colorado, Missouri, Oklahoma, Utah, and West Virginia had similar bills during past legislative sessions that would have allowed the wholesale importation of prescription drugs.6-10 Although none were enacted, their proposition shows that increasing prescription drug prices are a multistate issue.
There have also been 2 bills presented to the House in the past year that address lowering prescription drug prices through the importation of prescription drugs from Canada: the Improving Access to Affordable Prescription Drugs Act, along with its sister bill of the same name.11,12 A companion bill was presented in the Senate, as well, called the Affordable and Safe Prescription Drug Importation Act, which would allow a prescription drug to be imported into the United States only if it has the same active ingredient, route of administration, and strength as the drug in the United States, and the foreign seller must be certified by the FDA.13 Initially, the bill would allow for prescription drugs to be imported from Canada only, but if it is effective in lowering prescription drug costs in the United States, then after 2 years, the HHS secretary would be given the authority to approve prescription drug importation from other countries, as long as the drugs meet specific criteria.13
With the passage of this new law, Vermont has set a precedent that other states are likely to follow. As new rounds of legislation are introduced in ensuing legislative cycles, expect more bills to be presented across the United States that suggest the importation of prescription drugs as part of the solution to continually increasing drug prices.
Katelyn R. Brubaker is a PharmD candidate at the University of Kentucky College of Pharmacy in Lexington.Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy.