September 30, 2020

Drug Importation Executive Order

How it could work

The Executive Order on Increasing Drug Importation to Lower Prices for American Patients proposes to reduce costs of prescription drugs by allowing for the importation and re-importation of FDA-approved drugs from Canada. The policy aims to lower prices of costly prescriptions, most notably insulin products, by reducing trade barriers and increasing the exchange of drugs with countries that pay less for the same drug. This order also authorizes grants to individuals of waivers of the prohibition of the importation of certain prescription drugs, as long as the importation poses no additional risk to public safety and will lower costs to American patients.

What experts think

The expert panel was split on whether or not this executive order would reduce drug spending, though the majority stated that it would minimally reduce spending. Most of the experts agreed that there would be no change in either drug list or net prices, however two experts felt both would moderately decrease. The experts agreed that this policy would only increase drug access for uninsured patients, with no change in access to any of the other patient groups.

The majority of the panel agreed that this executive order does not advance drug spending policy. Experts unanimously agreed that both the size of the affected patient population and the magnitude of the drug spending impact are weaknesses of this policy. Other weaknesses of the executive order were reported to be its ability to be implemented and the evidence base in support of the order. The panel was split on if the precedent-setting value of the order was a weakness or strength, with five noting it as unknown, three as a strength, and one as a weakness.

How likely would this policy be to reduce drug spending?
Would Increase Drug Spending
Would Not Affect Drug Spending
Would Minimally Reduce Drug Spending
Would Moderately Reduce Drug Spending
Would Significantly Reduce Drug Spending
Would Substantially Reduce Drug Spending
How likely would this policy be to reduce drug prices?
Would Significantly Increase Drug Prices
Would Moderately Increase Drug Prices
Would Not Affect Drug Prices
Would Moderately Decrease Drug Prices
Would Significantly Decrease Drug Prices
List Prices
Net Prices
How likely would this policy be to increase patient drug access?
Would Significantly Reduce Drug Access
Would Moderately Reduce Drug Access
Would Not Affect Drug Access
Would Moderately Increase Drug Access
Would Significantly Increase Drug Access
Rare Disease
Large Patient Groups
How significant is this policy in the evolution of US drug spending policy?
Does Not Advance Drug Spending Policy
Minimally Advances Drug Spending Policy
Moderately Advances Drug Spending Policy
Significantly Advances Drug Spending Policy
Ground-Breaking Shift in Drug Spending Policy
What are the strengths and weaknesses of this policy?
Size of Affected Population
Evidence Base in Support of Policy
Precedent-Setting Value
Magnitude of Drug Spending Impact
How important are the following in your analysis of the policy's impact?
Not Important
A Little Important
Somewhat Important
Very Important
Uncertainty of international response (EU/OECD countries)
Does not change existing authority to allow drug importation
Standard of "no additional risk"
Degree of discretion that will be exercised by HHS Secretary
Unclear if targeted for individual patients or at a population level
Administrative burden in light of possible savings

Considerations for policymakers

Experts highlighted many considerations for policymakers. The most important consideration is the standard of “no additional risk.” There is currently no clarification on how any possible additional risk will be measured or monitored. Other key considerations include the uncertainty of international response (particularly EU and OECD countries), the degree of discretion that will be exercised by the HHS Secretary, and the administrative burden in light of the minimal possible savings. Additional considerations include that this executive order does not change the existing authority on drug importation and it is unclear if this is to be implemented for individual patients or at the population level.