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.
What a disappointment this editorial is, I have to say; your opinion is not shared by the food allergy community and it’s sad that even though this community supports you; your not willing to support them. You really missed the mark on this one.
I’m sure none of us want the auvi-q to return to the market prematurely. We all want them to find out wheres, whys and hows. Saying, as a community, that we are not giving up on this company does not mean that we don’t understand and support the recall. We, as a food allergy community, are all fighting the same battle. I will always support any company that tries to make our world safer and more user friendly!
What is really needed here is an affordable, well-designed reliable GENERIC epinephrine auto-injector, not two big pharmaceutical companies fighting over each other to make the most money profit possible off of the growing number of people with food allergies.
Mylan spends money on marketing and branding and sponsorships, not innovation, but they jack the price of their Epi-Pen devices up year after year. Those $0 copay coupons are all well and good, but the cost is still enormous for those who don’t have health insurance or don’t know about the coupons. There are plenty of children out there who don’t have Epi-Pens because of this pharma profit race.
And I was a huge fan of the innovative Auvi-Q design (if not its similarly inflated price) until this recall, but I don’t trust Sanofi now either. And I certainly did NOT enjoy having to pay over $400 for one of the replacement Epi-Pen Jr. sets (insurance didn’t cover all the sets I needed right away for home and school, and I won’t be reimbursed for over a month), or the feeling that I had been carrying around what I THOUGHT were life-saving devices but could have left my daughter without the medicine she needed in case of anaphylaxis.
P.S. So I am sort of agreeing with the editorial, but what I don’t want to agree with is the idea that the allergy community owes “support” to the pharmaceutical companies. Sanofi already got over $1,500 out of me and my health insurance company, so they already had my financial support (whether I liked it or not).
I think auvi-q may be experiencing a financially crippling situation and epi pen has more money than they know how to spend. What if the two get together and develop an even smaller and better injector to deliver the amount necessary and not cut someone’s leg. If they work together maybe they can develop something more user friendly and less expensive for the consumer. Just a thought
First let me say, yes we realize that the Auvi-Q needs to be functioning when it returns to the market. We are not chancing our children’s life. Yes we returned them. Yes we now have 2 sets of the Epi-Pen. But to speak against us encouraging the company to fix the errors and reintroduce them into the market sounds more like editorial written to line your pocket by The manufacturer of the Epi!!! I think the company was upfront, forthcoming and value the lives of our children. So I think this VOLUNTEERY recall was amazing. They are loosing large quantities of money. So when they bring it back onto the market I myself with trust that they have the issues worked out and will save my child’s life…..
Tiffini, a voluntary recall is one where the manufacturer issues a recall before being compelled to do so by the regulating authority. This does not mean Sanofi took steps out of the goodness of their hearts… they received a number of reports of malfunctions and knew that if they didn’t take action, the FDA eventually would.
Sanofi is a huge corporation and this recall is the result of balance sheet calculations by them and their legal staff. They evidently brought a defective device to market in the first place… why would you be so quick to trust them the next time around? And would you be so quick to forgive them if your child was one whose Auvi-Q malfunctioned while they were in the midst of an anaphylactic reaction?
We haven’t scratched the surface of this issue… let’s let Sanofi respond before professing that “We Love Auvi-Q… we’ll come back!”
I agree Dave.
Considering that you get paid to advertise for the Epi… Your article is a complete conflict of Intrest. Frankly as someone who is on the payroll for Epi, you should not be even writing an article on this. And yes it hey knew it was coming. They could have waited but by didn’t want to endanger lives…. So Frankly your editorial is bias and trying to protect your pocketbook…
Oh and They got 20 notices. Out of hundreds of thousands of pens. Not one person died, they needed a second injection. Lets see how many notices Epi pens have had?
I think this editorial is spot on and takes a very non emotional look at the issue. All it is saying that we should not rush to welcome it back until all the defects have been corrected and that they ensure everything possible will be done not to have it occur again. I for one would not want it back on the market or rushed to market until it is proven safe to use. The same people calling supporting the company now would be the same ones calling for lawsuits if the device did not work for them. All this is saying is it can be a great device but lets make sure it is safe and effective.
After being invited to participate in yesterday’s teleconference call with Sanofi, I feel confident that Sanofi is proceeding as they feel is the best way to do so at this point in time. I am grateful our family has other epinephrine options in case of an emergency but I also understand that this has just happened so recently that everything MUST be looked at and fixed precisely. Is convenience and rushing into reintroduction worth the life of your child or a family member? Everyone is upset but everyone also has a back-up option until everyone has the details. Respectfully, I think we all need to be a bit more patient, take a deep breath, let Sanofi get answers for our questions and just be prepared in the meantime. We use both Auvi-Q’s and EpiPens and (again) whichever is with my child and functions during an allergic reaction is the one that will be used.
Don’t sign it then. And good luck waiting for a fail proof device, because no such thing exists. Mylan gets malfunction reports too. And when we compare fail rates let’s not forget to include human error which I believe is substantially higher for Epi-pens. I bet the boy who died in Italy last week would be alive if he’d had a recalled AuviQ instead of an epi-pen.
Completely premature. I know it will be quite awhile before Sanofi works out the kinks and gains their customer base back. Two recalls within 5 months, unacceptable.
Thank you for this editorial. People who vocally favor the Auvi-Q do so because of its convenience. Most of us have never had to use either the Auvi-Q or Epi-Pen. We or our children carry them just in case. The Auvi is smaller and is potentially easier to use. Clearly, there is an issue with the Auvi. There are rarely recalls for an entire product – usually only specific lots/dates. Perhaps an Auvi did save your child’s life – if so, it could be that you and your child were lucky and not because the Auvi is superior to the Epi-Pen. We just don’t know yet. But it could very well be that this is a faulty product and just because you liked it, doesn’t mean it wasn’t faulty.
And to Aaryn, above, please do not claim you are speaking for the “food allergy community.” There is a vocal minority right now that is speaking in favor of the Auvi-Q. Vocal minority. Most people in the “food allergy community” do not belong to online support groups or take an advocacy stance – they’re just living their lives. And most likely would favor an auto-injector that works whether it slips into a pocket or has to be carried in a suitcase.
The petition clearly addresses the fact that the product must be proven safe and effective before returning to market. Absolutely nothing premature in letting Sanofi know that if they are able to do that, we will return to the Auvi-Q.
The petition also lets others who may be contemplating entering the market that there is an opportunity to capture market share with the right device.
Great petition. Glad to have had the opportunity to sign it.
Personally, I will continue buying Auvi-Qs if they are returned to market because my daughter can use an Auvi-Q, but cannot use EpiPen.
I’m not returning my Auvi-Q because less than the promised dose is better than an EpiPen that not all of us can use. The new (not round) EpiPen that is spring-loaded takes significantly more) EpiPen takes significantly more force to fire than the gas powered Auvi-Q. We always keep 2 Auvi-Q and 1-2 EpiPens around at each dose due to all 3 of us having allergies. [I am not recommending this approach as epinephrine is a dangerous medication to receive an inaccurate dose]
The Adrenaclick and the authorized generic (epinephrine auto injector) are the only other alternative to EpiPen, which is more complicated that AUvi-Q.
We had the Auvi-Q at my daughter’s school as well as at home. Three year old brother knew how to use it and train friends and family. We pushed for a district wide training at school because we liked the Auvi-Q. Now, after a total product/brand recall with no publicized plan; our family switched to the Epi-Pen. I don’t care how cool, easy, small your device is. If it doesn’t work and there is no assurance that it will-we’re out! What I like is a product that is guaranteed to work…every single time.
Please bring the Auvi Q back. I have severe allergies and hate using EpiPen that malfunction.