If you haven’t seen it yet on social media, there’s no doubt you will: A petition to the Chief Medical Officer of Sanofi urging him to quickly bring the Auvi-Q® epinephrine auto-injector back to market. Here is the text from the petition:
As people with life-threatening allergies or parents of allergic children, we appreciate that the Auvi-Q is an awesome innovation, and we want you to know we are not giving up on you. We hope you are not giving up on us! Setbacks are a part of innovation, and we trust you will work quickly and diligently to fix the problem. Please bring the Auvi-Q back on the market as soon as possible, and we will be there to fill our prescriptions. Thank you!
The petition is in response to a recall by Sanofi of all its Auvi-Q and Allerject® branded auto-injectors from the US and Canadian markets due to numerous reports the device potentially delivered less epinephrine than advertised or none at all. [See Chronology of the Perfect Storm That Hit the Food Allergy Community.]
We understand the draw of the Auvi-Q given its small form-factor and innovative verbal instructions that guide the user through the administration process. It’s a terrific option for children and adults alike – if only it worked as advertised.
We also understand how the withdrawal of the Auvi-Q will affect the US market. Mylan – Sanofi’s competitor whose EpiPen® brand auto-injector owns the lion’s share of the market – is now left as the only major provider with the exception of a lesser-known generic. Competition is key to a healthy and evolving market and the elimination of a major competitor can only hurt consumers in the long run.
That said, we at SnackSafely.com believe the petition is premature. Before urging Sanofi to return the Auvi-Q to market, we need to know much more about the shortcomings of the device entrusted to safeguard our family members.
First, the firm needs to fully disclose the cause of the problem. Was it a design flaw that should have been caught during the testing phase? A manufacturing issue? A failure of quality assurance procedures?
Second, Sanofi must articulate how they will address the present issues and how they will ensure the safety and efficacy of the device moving forward. Specifically, what assurances will we have that future Auvi-Qs won’t be prone to similar issues? What procedures will the firm implement to ensure that faulty auto-injectors never leave the factory? What will the firm change to prevent subsequent recalls of the device?
Only after Sanofi provides detailed answers and proper assurances should consumers welcome the Auvi-Q back to the marketplace.
In closing, we should keep in mind that the failure of any epinephrine auto-injector could potentially mean the difference between life and death. Before urging a manufacturer to reintroduce their product, we must first be reassured the company has earned back our trust.
The lives of our loved ones depend on it.
Disclosure: Mylan is an advertiser with SnackSafely.com. Until the recall, the author’s family depended on both Auvi-Q and EpiPen brand auto-injectors.