Buying prescription drugs from Canada, where prices are much lower, is illegal. But the Trump administration is taking steps to legalize the purchase of some drugs from north of the border.
Two federal agencies -- the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) -- this week issued a notice of proposed rulemaking to allow the importation of certain drugs to address high costs of the same drugs in the U.S.
The proposal must be submitted for a comment period before it can become final. Drug companies have adamantly opposed such a move in the past and can be expected to oppose the change in U.S. policy.
At the same time, the administration has announced new draft guidance for drug manufacturers to follow to ease the process of importing prescription drugs that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
The object is to lower costs to consumers
The proposed rule is aimed at lowering drug costs for consumers while making sure that imported drugs pose no additional risk to public health. Under the draft guidance, drug companies would be required to certify that the drug being imported is FDA-approved.
"Today's announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients," said HHS Secretary Alex Azar. "The president has recognized the opportunity to lower costs for American patients through safe importation, and we at HHS and FDA are delivering on that possibility through a safe, commonsense approach."
Lowering prescription drug costs has been an issue uniting Republicans and Democrats lately. During the 2016 presidential campaign, Trump called for steps to cut drug costs, as did Sen. Bernie Sanders (I-Vt.), who at the time was seeking the Democratic presidential nomination.
Issue gains traction
In June, the Senate held a series of hearings on the impact of rising drug prices. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research for the FDA, told the committee that the agency is working to increase the number of generic drugs on the market as a way to lower prices.
Woodcock said the agency wants to curb list price increases, reduce the financial burden on beneficiaries, improve transparency, and reduce the risks associated with rebates inappropriately influencing formulary placement or inducing business payable by Medicare Part D or Medicaid.
The FDA’s proposed rule would allow states and organizations that want to import drugs from Canada to submit proposals to the FDA for review. The rule would establish a system to allow pharmacists, wholesalers, and other non-government organizations to apply for permission to establish an import program.
Under the plan, not all drugs would be eligible for import to the U.S. Drugs that meet the eligibility requirements would have to be relabeled with the required U.S. labeling prior to importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet FDA standards.
They would also have to be cheaper than their cost in the U.S.