AUGUSTA, Maine — Maine has begun developing a plan to import prescription drugs from Canada under a new law without guidance from the federal government, which will eventually have to sign off on the state roadmap.
Any plan that would allow certain drugs to be bought from Canada is subject to federal approval, but no formal guidelines have been issued since the U.S. Food and Drug Administration released two potential pathways for importation plans in July in a positive sign for states mulling access to price-controlled Canadian drugs.
Maine does not want to wait for those guidelines to develop a plan and seek approval, said Department of Health and Human Services Commissioner Jeanne Lambrew, whose department proposed rulemaking for the plan on Thursday. The rules will be subject to legislative approval.
The state has until May 1, 2020, to submit a plan under a bill passed earlier this year, modeled after a first-of-its-kind Vermont law. Other states that have approved drug import plans are taking similar actions. Colorado is making rules, and Florida submitted a plan in August.
Vermont — which became the first state to adopt a law allowing drugs to be imported from Canada in 2018 — sought guidance from the federal drug czar in August. An FDA spokesperson was unable to provide a timeline on when federal guidelines would be released.
Lambrew said there are four main things the department has to consider when developing its program: which drugs will be sold under the program and how the list would be updated, how the public would access the drugs, how to monitor the programs, and how to build the program’s infrastructure.
The importation plan was one of four bills meant to lower prescription drug prices in the country’s oldest state by median age passed earlier this year. Federal officials have been unwilling to allow such measures, citing safety concerns, although Canada and other countries have similar safety standards.
A law that allowed Maine residents to purchase Canadian drugs by mail was overturned by a federal judge in 2015. Officials in Canada have not been keen on import plans, arguing that they may impact Canadians’ access to prescription drugs, Reuters reported in July.
It’s also unclear how much money importation plans could save residents. The National Academy for State Health Policy said Vermont’s program could save residents between $1 million to $5 million a year, but that analysis did not consider that insulin — a costly drug used to treat diabetes — is not eligible for importation. The study also did not take into account for a third insurance agency in the state, according to the Associated Press.
The department will hold a public hearing on the rulemaking Dec. 2 and will accept public comment on what the rules should look like until Dec. 12.