Final regulations released governing Canadian drug importation

What are the challenges of implementing this policy? And what do the Canadians think? Learn here.

Opinion: Trump Offers False Hope with Canadian Drug Plan, Detroit Free Press, 10/15/2020
"...the Trump administration should dispense with the gimmicks and come up with proposals that truly help Americans better afford their medicines while also preserving consumer access, market pricing, and patient safety."

"FDA, CMS Actions on Drug Importation Promise Much, Likely Deliver Little," Lexology, 10/13/2020
"...although the regulation, guidance, and releases may be intended to foster importation of foreign drugs with the goal of reducing prices paid by U.S. consumers, we expect statutory, regulatory, and procedural barriers to substantially delay (if not totally prevent) any drug importation under these pathways."

"New Rule on Foreign Drug Importation is Likely to Result in Additional Costs, Undercutting Cost-saving Goal," Healthcare Finance News, 10/7/2020
"The potential costs are numerous. The sponsor incurs costs when they organize and submit proposals for approval. The manufacturer incurs testing costs, and the importer incurs costs because of the statutory testing required to gauge degradation, not to mention the costs associated with repackaging and labeling of the drugs to comply with U.S. standards."

"Experts Uncertain If the President’s Drug Import Plan Will Save Consumers Money," Healthline, 10/3/2020
“I do think opposition from both Canadian regulators and pharmaceutical firms will limit its potential impact, even if it survives litigation...Because these problems are foreseeable, it’s disappointing to see the administration pursuing this strategy when others might be more beneficial."

NABP Position Statement on New Federal Importation Rules, 10/2/2020
"...each separate proposal effectively creates a new and distinct prescription drug supply chain that will require state regulatory oversight and monitoring, only with fewer protections. This patchwork approach is a step away from the tightly regulated supply chain and safeguards currently in place to ensure the efficacy and safety of prescription medications. The National Association of Pharmacy Regulatory Authorities, NABP’s counterpart in Canada, has expressed concern that exportation of medicines out of Canada will threaten the supply available to its citizens. This, in turn, will increase the opportunity for counterfeit medications to enter its supply chain, endangering both US and Canadian patients."

"APhA: New Federal Drug Importation Program Puts Patients at Risk," American Pharmacists Association, 9/25/2020
"Together with colleague pharmacy organizations, countless concerned pharmacists, and consumers, we opposed the December 2019 proposed rule and emphasized to FDA that patient safety cannot be compromised. FDA failed to consider the thousands of comments that opposed finalizing this program."

FDA, HHS Allow States to Import Drugs From Canada,Becker Hospital Review, 9/25/2020
“The final rule released by President Donald Trump's administration permits states to purchase drugs from Canada, which are often much cheaper than drugs manufactured in the U.S. since the country's laws put a cap on how much drugmakers can charge. States that have already sought federal permission to import drugs from Canada include Florida, Colorado, Maine, Vermont, New Hampshire and New Mexico.”

Trump Forges Ahead With Drug Import Plan, but Impact in Doubt,BioPharma Dive, 9/25/2020
“With the election just over a month away, the administration has now turned to importing lower-price drugs from overseas, and use savings from that plan to offer some $6.6 billion in discount cards to Medicare recipients. This is based an old idea, however: The U.S. Department of Health and Human Services has had the power to authorize such an action since 2000 if it cuts costs and if the drugs imported are safe and effective. HHS has never done so.”

Costly Drugs Left Out of Import Rule Blunt Projected Savings,Bloomberg Law, 9/25/2020
“The Trump administration can’t say yet how much patients may save or how much it may costs states to draw up their own plans to import pricey drugs from Canada.”

"CPhA Continues to Call For Action to Protect Canada's Drug Supply," Canadian Pharmacists Association, 9/25/2020
There must be strong and unequivocal action by the Canadian government to restrict the bulk exportation of drugs from this country. While Canada’s largest pharmaceutical wholesalers have all pledged that they would not participate in such schemes in order to protect Canada’s drug supply, government measures are still needed to close potential loopholes and tighten the existing regulations.

Council for Affordable Health Coverage, 9/25/2020 (PDF copy)
"This final rule brings a false promise to Americans...Drug makers will not sell excess supply to Canada and other countries. And Canada will not ship drugs off to US Consumers at the expense of their citizens...Worse, doctors, other prescribers, and pharmacists may no longer trust the medicines they prescribe are safe and trusted."

FDA Finalizes Rule For Canadian Drug Importation,Drug Store News, 9/25/2020
“In addition to noting the potential for the move to create supply chain vulnerabilities that might lead to the introduction of counterfeit or unsafe drugs, APhA also said it undercuts track-and-trace safeguards in the Drug Supply Chain Security Act.”

Administration Finalizes Drug Importation Plans, But Legal And Practical Questions Remain,Health Affairs Blog, 9/25/2020
“I cannot catalog all of the practical and legal obstacles that may stand in the way of the importation rule in this blog post (PhRMA’s comments on the NPRM alone were 81 pages long, for context), but I want to focus on three key challenges the rule will face going forward, and more briefly identify a range of others.”

HHS to Allow For the Importation of Certain Drugs from Canada and Other Countries,Healthcare Finance, 9/25/2020
"The Administration has chosen to pursue the most favored nation policy – an irresponsible and unworkable policy that will give foreign governments a say in how America provides access to treatments and cures for seniors and people struggling with devastating diseases," he said. "What's worse is that they are now expanding the policy to include medicines in both Medicare Part B and Part D, an overreach that further threatens America's innovation leadership and puts access to medicines for tens of millions of seniors at risk."

"Trump Approves Final Plan to Import Drugs From Canada ‘for a Fraction of the Price’," Kaiser Health News, 9/25/2020
"But pharmacists in Florida and across the country oppose drug importation, saying they don’t think it will ensure that counterfeit drugs are kept out of the U.S. market. The Canadian government told HHS last spring that the country doesn’t have enough drugs to spare and that the Trump plan would only worsen shortages of medicines there."

"Trump Makes His Final Health Care Play," Politico, 9/25/2020
"The rule is not considered economically significant, meaning it’s unlikely to have any substantial impact on pharmaceutical spending. And the proposal could quickly be challenged in court."

"Trump Promises Seniors $200 Prescription Drug Gift Certificates, But Questions Abound," Stat,  9/24/2020)
"While the administration did publish a Food and Drug Administration regulation on importation Thursday, states would still need to apply to participate and then would have to set up new programs to actually begin importing drugs."

Pharmacy Groups Blast US Importation of Drugs From Canada,” Becker’s Hospital Review, 9/28/2020
"The American Pharmacists Association said that the rule, which was published Sept. 25, jeopardizes patient safety by creating supply chain vulnerabilities that could introduce counterfeit or unsafe drugs.”

"Lower Drug Prices: Paper Promise or Actual Change?" BioSpace, 9/28/2020
"...Alexander Gaffney of Politico’s AgencyIQ tweeted on Thursday, 'There's also a bunch of new language that allows the FDA to revoke importation programs because - get this - it is 'too much of a burden on FDA or HHS resources.' That seems like a blank check to end these programs whenever it wants.'”

"Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act,The National Law Review, 9/28/2020
"...the Final Rule notes several times that HHS/FDA is “unable to estimate the cost savings from this final rule...making it difficult to reconcile how the HHS Secretary was able to certify that it would result in a significant reduction in costs for U.S. consumers."

Major Developments

5:30pm Pacific: Screenshots of HHS Secretary Alex Azar's Letter to Congress certifying that Canadian drug importation is safe and will give American significant savings.

3:30pm Pacific: Final rule  on PATHWAY 1 (Canadian drug importation) appears on the HHS website, HHS posts requests for proposals for PATHWAY 3 (waivers for individual prescription drug importation) and PATHWAY 4 (insulin reimportation programs) with an accompanying FAQ for the latter.

3:00pm Pacific: The President announced in North Carolina that these regulations are final and effective immediately. FDA and HHS issued accompanying statements.

5:45am Pacific: The Office of Management and budget cleared the final regulations for PATHWAY 1 governing how states can apply to HHS for permission to bulk import medicine from Canada.

Key Documents

Pathway 1: Wholesale Canadian Drug Importation

  • Final rule (PDF, 179 pages)
  • Redline (shows differences from December's draft rulemaking).

Pathway 2: Manufacturer Reimportation

Pathway 3: Individual Waivers for Personal Importation

Pathway 4: Reimportation of Insulin