Canada Gazette, Part I, Volume 152, Number 37: ORDERS IN COUNCIL

September 15, 2018

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Order Approving the Interim Order Respecting Epinephrine Auto-injectors

P.C. 2018-1087
September 4, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to paragraph 30.1(2)(a) footnote a of the Food and Drugs Act footnote b, approves the Interim Order Respecting Epinephrine Auto-injectors, made by the Minister of Health on August 27, 2018.

EXPLANATORY NOTE

(This note is not part of the Order.)

Proposal

The Order approves the Interim Order Respecting Epinephrine Auto-injectors (the Interim Order) made by the Minister of Health on August 27, 2018. The Interim Order permits the immediate importation and sale of epinephrine auto-injectors, sold under the brand name AUVI-Q® (0.15 mg and 0.3 mg doses) and authorized by the United States Food and Drug Administration for use in the emergency treatment of life-threatening allergic reactions.

Without the Order, the Interim Order would, in accordance with paragraph 30.1(2)(a) of the Food and Drugs Act, cease to have effect 14 days after it was made. As a result of the Order, the Interim Order will, in accordance with paragraphs 30.1(2)(b) to (d) of the Food and Drugs Act, cease to have effect on the day on which it is repealed, on the day on which regulations having the same effect come into force, or one year after the day on which the Interim Order is made, whichever is earliest.

Objective

The objective of the Order is to ensure the continued effect of the Interim Order, which addresses the significant risk to the health of Canadians as a result of a shortage of epinephrine auto-injectors. This Interim Order represents one of a number of actions to help address a critical shortage of a life-saving drug.

Background

Epinephrine auto-injectors are life-saving drug delivery products used in the treatment of life-threatening allergic reactions in adults and children. The Canadian market for epinephrine auto-injectors is currently supplied by Pfizer Canada’s products EpiPen (0.3 mg dose) and EpiPen Jr (0.15 mg dose for children weighing between 33 and 66 pounds), manufactured by Meridian in the United States and imported by Pfizer Canada.

Supplies of EpiPens have been in shortage globally for several months due to manufacturing issues and it is unclear when the situation will be resolved. These issues have resulted in limited importation of supplies into Canada. Health Canada communicated publicly advising Canadians of the shortage in January and April 2018. On July 30, 2018, Health Canada further advised Canadians of the limited supply and likely depletion of the supply of EpiPens in the 0.3 mg format at pharmacies across Canada. Supplies of EpiPen Jr are also limited. The beginning of the school year has historically been a time of peak demand for the 0.15 mg dose. Moreover, the monthly demand for both doses is anticipated to increase significantly once product becomes available as people have been coping with limited supply for several months.

Health Canada has identified an alternative supplier, Kaléo Inc., whose epinephrine auto-injector product, AUVI-Q®, is authorized for sale in the United States. This product is comparable to another product by the same company that has been authorized by Health Canada previously, but that is not currently marketed in Canada. The most significant difference is that the U.S. product does not include French labelling and instructions. Health Canada will address this difference by requiring that instructions in English and French be provided to all consumers.

Implications

The Interim Order permits shipments of AUVI-Q® (0.15 mg and 0.3 mg doses) to be imported from the United States and sold in Canada.

In order to be sold to consumers in Canada, AUVI-Q® will need to be accompanied by the U.S. approved patient information, available in French and English on Health Canada’s website.

Most provisions in Part C of the Food and Drug Regulations will not apply to the importation or sale of AUVI-Q®. However, requirements relating to the reporting of serious adverse drug reactions, recall by the manufacturer and the ministerial power to order a test or study will continue to apply. In addition, AUVI-Q® will be required to be imported by an importer holding an establishment licence issued by Health Canada.

Consultation

Representatives of provinces and territories and pharmacist associations have been made aware of the Minister’s intent to take action to address the shortage of epinephrine auto-injectors. They have indicated their support for the Interim Order as a mechanism to facilitate an improved supply of life-saving products for Canadians.

Contact

Kim Dayman-Rutkus
Director
Policy and Regulatory Strategies Directorate
Regulatory Operations and Regions Branch
Health Canada
Address Locator: 1907A
200 Eglantine Driveway
Jeanne Mance Building
7th Floor, Room 705A
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 613-954-6785
Email: kim.dayman-rutkus@canada.ca