July 29, 2020 video: Importation Executive Order Explainer

On July 24, 2020, the White House issued an executive order  to implement three approaches to foreign drug importation. To be clear, this isn’t normal importation of medicine. Food and Drug Administration (FDA)-regulated manufacturers routinely make medicines in other countries to be sold on the U.S. market. The executive order, however, involves dipping into other countries’ drug supplies and putting them in U.S. medicine cabinets.

Before this announcement there were two pathways outlined in draft regulations for importing medicine from other countries drug supplies:

  • Pathway #1: State-sponsored importation programs from Canadian suppliers that must be approved by HHS.
  • Pathway #2: Manufacturer-sponsored importation of their own products into the United States.

The July 24, 2020 executive order reaffirmed the White House’s commitment to completing the regulations for Pathway #1, and created two new pathways: individual waivers for personal importation and insulin for emergency medical care.

Individual Waivers (Pathway #3)

The first importation option listed in the order references section 804(j)(2) of the Food, Drugs and Cosmetics Act (FDCA), which allows the U.S. Department of Health and Human Services (HHS) to grant individuals waivers—either on a case-by-case basis or by regulation—to import medicine and medical devices for personal use. The next paragraph of the law, 804(j)(3), specifies that any imported medicine must be:

  1. Imported with a valid prescription from a licensed pharmacy in Canada, from a seller registered with HHS.
  2. An FDA-approved drug manufactured in an FDA-approved facility sold in the final form that the FDA has permitted.
  3. Imported under conditions that HHS has determined ensures public safety.
  4. No more than a 90-day supply.

Although importation proponents have asserted that the FDCA permits personal importation in the past, the actual code shows how narrow that permission is: importation is only legal if the HHS secretary has granted a specific waiver; the patient must buy from a list of HHS-approved sellers who are licensed in Canada, and the drug being imported must be FDA-approved and manufactured in a facility registered with the FDA. Brokers taking orders on a website with a Canadian flag and filling them with drugs from all over the world were not legal on July 23rd. And they’re still not legal today.

Insulin for Emergency Medical Care (Pathway #4)

The second part of the executive order directs the Secretary of HHS to use their powers to bring insulin in from other countries under the authorization granted for “emergency medical care” in Section 801(d)(2) of the FDCA. Access to insulin is unquestionably critical for the more than 8.2 million U.S. residents who have insulin-dependent diabetes. As the government of Canada has noted, however, Canada accounts for only two percent of global drug sales, and the United States accounts for 44 percent, and Canada is not in a position to increase its share of medicines to sell them to the U.S. If Canada were to allow the U.S. import insulin in bulk from our northern neighbors it would cause drug shortages and Canadian deaths.

Public comment on Pathway #1
ran 20-to-1 against the proposal. Learn more.

Finish the Rulemaking for State Importation (Pathway #1)

The final part of the executive order directs HHS to complete the rulemaking posted in December 2019 that would allow wholesalers, pharmacists, and by proxy, states to import Canadian medicine in bulk. PSM examined the proposed rulemaking and concluded that it would increase the risk of members of the U.S. public receiving counterfeit, adulterated, misbranded, or otherwise unsafe medicines. We also reviewed more than 1200 public comments posted in response to it once the comment period had closed and found that members of every part of the pharmaceutical supply chain in the U.S. and Canada thought that state importation was a bad idea that, as the Healthcare Distribution Alliance wrote this week, would have “significant implications for the safety and security of the pharmaceutical supply chain and patient health.”

We Cannot Solve This Problem by Raiding Canada’s Drug Supply

Canada’s population is one-ninth the size of ours and it already faces substantial drug shortages. 65% of their drug supply is manufactured overseas, so they cannot simply increase their production to accommodate the needs of U.S. residents. The Canadian prescription drug supply would last approximately 182 days if twenty percent of U.S. prescriptions came from Canada.

For 18 years, no head of HHS or FDA under any president has endorsed importing Canadian drugs, and many previous FDA commissioners and HHS secretaries have gone on record against it. Law enforcement, patient groups, and healthcare professionals from every province in Canada and all over the U.S. oppose importation.

Illinois, Maine, and Minnesota have tried rogue Canadian importation programs in the past with poor results in terms of safety and cost. There is no reason to believe that they will fare better now. States across the entire country are facing critical budget shortfalls because of the COVID-19 pandemic, but the White House is telling states to move forward with drug importation anyway.  Florida has already allocated eleven million dollars to fund importation programs while gutting programs that would have brought drinkable water to Pasco County, raised pay for caregivers to the disabled, and treated inmates with contagious and deadly hepatitis C. In Colorado, importation is being considered alongside important education, housing and healthcare initiatives. All this, despite the fact that our Canadian counterparts have rejected the idea

Sources for this week's video and blog

Resources from The Partnership for Safe Medicines: