September 3, 2016

Many parents have asked what happened to Auvi-Q. The talking auto-injector was the Siri of the food allergy world. It was a device that spoke to parents and patients, taking them through the exact steps of what to do and how to use the auto-injector in case of a life-threatening reaction.

It was enormously popular and brought to market by twin brothers, Eric and Evan Edwards, who had a lifetime of food allergy experience. They’d designed a product that was easy to carry, a better design and a smarter technology. It took off.

The New York Times covered the story in February of 2013. Families with life-threatening allergies loved it.

And then suddenly, there was a recall, based on 26 unconfirmed reports. The entire product line was recalled, just as the company hit 10 percent market share.

A Sanofi spokesperson is on record with the FDA saying they were unable to locate a single faulty device. According to the FDA, “None of these device malfunction reports have been confirmed.”

It didn’t matter, the entire line was shut down.

Many have wondered what happened, but perhaps nothing shines a light on just how much of a threat Mylan saw this competitor than what happened in their own home state of West Virginia in 2015.

Back in 2015, West Virginia Department of Health and Human Resources announced that they wanted to switch the preferred provider to Auvi-Q, as it gave voice directions and would save the state money.

Mylan was not at all happy with the announcement and filed suit against the state.

According to the Charleston Gazette Mail Newspaper, a Kanawha County Circuit Court judge denied a request from Mylan Inc. to block part of a new list of preferred drugs from taking effect for Medicaid patients, after the company unsuccessfully argued that the West Virginia Department of Health and Human Resources violated the state’s open meeting laws in replacing one of Mylan’s drugs with a competitor on the list.

In other words, as the state tried to introduce competition into the system, Mylan sued and lost.

West Virginia Medicaid then makes Auvi-Q the preferred autoinjector for Medicaid. Now, patients could still get an Epipen with a doctor’s note, but new patients would mainly be prescribed an Auvi-Q.

The West Virginia Public Employees’ Insurance Agency and the Children’s Health Insurance Program both moved to make Auvi-Q the preferred drug for their enrollees. Now, all three were making the switch.

The local West Virginia newspaper broke the story on March 31. Almost exactly 7 months later…Oct 30, Auvi-Q was recalled and all of the state program-covered patients who had purchased Auvi-Q now had to be prescribed new Epipens.

On November 4, despite making the Auvi-Q its preferred epinephrine injector for Medicaid recipients earlier this year, the West Virginia Department of Health and Human Resources was forced to revert to offering the EpiPen after a nationwide Auvi-Q recall.

As reports of this story come in from West Virginia, please continue to share any insight on incidences that have occurred in your state around EpiPen mandates and the Auvi-Q recall.

Members of Congress are investigating whether Mylan may have violated antitrust law.

Additional information can be found here http://www.wvgazettemail.com/article/20150331/GZ01/150339818/2004012912

See more at: http://www.wvgazettemail.com/article/20151104/GZ01/151109708/1101#sthash.Wy2FXKCy.dpuf