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Trump administration to allow Canadian drugs to be imported
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Trump administration officials recently unveiled the Safe Importation Action Plan, a two-pronged historic approach that they said provides the groundwork for allowing certain drugs that were originally intended for foreign markets to come to the U.S. instead.
“For the first time in HHS history, we are open to drug importation,” Alex Azar, HHS Secretary, said in a conference call with reporters. “Entities ... that can convince us that they have a workable plan that protects the integrity and safety of the American drug supply chain, protects patient safety and will deliver lower costs ... finally have a pathway.”
Ned Sharpless, MD, acting FDA commissioner, provided specific details on the Safe Importation Action Plan.
The first component would “involve a notice of proposed rulemaking that would ... when the rule is finalized, authorize demonstration projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval,” he said.
The second component would draft guidance that enables the FDA “to describe recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the United States,” Sharpless said.
The components have varying levels of restrictions, according to Azar.
“The key point of the first pathway would be implementation of a statute that is limited to Canada and excludes certain classes of drugs, such as biologics, controlled substances and IV drugs. The second pathway would be potentially open to all countries and all drugs,” he said.
Neither Azar nor Sharpless provided a timeline for the plan’s implementation, and they said that they anticipated that “hurdles and barriers” will need to be overcome to bring the Safe Importation Action Plan to fruition.
Healio Primary Care has previously reported that at least 17 states have introduced drug importation bills this year and three — Florida, Colorado and Vermont — have enacted laws for wholesale implementation that would lower the price of drugs, according to the National Academy for State Health Policy. Any state law allowing the importation of drugs would need HHS approval. Mainstream media has reported that President Donald J. Trump has verbally supported Florida and Connecticut’s efforts and directed Azar to find a way to make those states laws be approved.
Though the general consensus is that imported drugs would be less expensive, there are varying opinions on the safety of prescription drugs that come from other countries.
“Importing drugs in this particular way cripples the patient-pharmacist relationship that is an important link in the medication safety chain and compromises the ability of the pharmacist to relay important information back to the prescribers,” C. Michael White, PharmD, of the department of pharmacy practice at the University of Connecticut, said in an earlier interview. “In addition, this type of imported drug could be coming from a variety of sources and being mailed in from several countries, compromising the ability to detect and mitigate drug interactions or to provide medication therapy management.”
Those concerns are nonsense, Joel Lexchin MSc, MD, a practicing physician and professor emeritus at the School of Health Policy and Management at the University of Toronto.
“The mere fact that drugs cross a border does not render them suspect. There are no Canadian bodies lying on the street from the drugs that they consumed here and similarly there won’t be any American bodies lying on the street if they use drugs imported from Canada,” he said in Healio’s previous story.
The Safe Importation Action Plan that Azar and Sharpless introduced today is one of many strategies the Trump administration has proposed to lower the price of prescription drugs. These strategies have had mixed results, such as promoting competition and access to drugs and granting waivers to states that would allow states to negotiate pricing contracts with drug makers. But other initiatives have met setbacks, including the recent district judge ruling that blocked the HHS rule that certain drugs prices be included in TV ads, saying HHS overstepped its authority in issuing such a requirement. Stay tuned to Healio for continuing coverage. – by Janel Miller
Disclosures: Azar is HHS secretary, Sharpless is acting FDA commissioner.