AS EPIPEN SHORTAGE CONTINUES, BLUMENTHAL CALLS FOR HHS ACTION TO ENSURE ACCESS TO EPINEPHRINE AUTO-INJECTORS
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AS EPIPEN SHORTAGE CONTINUES, BLUMENTHAL CALLS FOR HHS ACTION TO ENSURE ACCESS TO EPINEPHRINE AUTO-INJECTORS
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Specifically, Blumenthal asks Azar to allow importation of safe and approved epinephrine auto-injectors from foreign countries to provide a temporary, immediate supply. Second, noting that many insurance companies do not cover available EpiPen alternatives, Blumenthal calls on the
"I write to you regarding the persistent, serious shortage of the widely used EpiPen Auto-Injector as we begin a new school year. As you know, this lifesaving drug provides treatment and security to millions of Americans, including children, who suffer from severe allergies. The prolonged shortage of EpiPen is simply unacceptable. I urge the
Full text of the letter is copied below and can be found at: https://www.blumenthal.senate.gov/download/epipen-letter.
Dear Secretary Azar,
I write to you regarding the persistent, serious shortage of the widely used EpiPen Auto-Injector as we begin a new school year. As you know, this lifesaving drug provides treatment and security to millions of Americans, including children, who suffer from severe allergies. The prolonged shortage of EpiPen is simply unacceptable. I urge the
When I wrote to FDA Commissioner Gottlieb in May, I expressed my frustration that this current shortage has persisted. Despite assurances that the shortage was occurring on an "intermittent" or "isolated" basis, evidence has showed the shortage is much more widespread.[1] Further, FDA declared in early May that it anticipated this shortage to be "short-term" based on assurances from manufacturers.[2] Unfortunately, as August ends, press reports and patient accounts prove that this is not the case.[3]
In the coming weeks, more than 6 million families will be restocking on their epinephrine supplies as children go back to school.
While I am encouraged by the fact FDA recently approved the first generic epinephrine auto-injector, this product may not become available to consumers in the near future.[4] Further, while FDA recently extended the expiration date on some EpiPens to help mitigate the shortage[5], more can and must be done.
First, as FDA did with intravenous (IV) saline following Hurricane Maria, the safe importation of approved epinephrine auto-injectors from foreign countries should be approved to immediately combat the effects and duration of the shortage. The imports provided temporary relief to hospitals and other facilities. Individuals and families deserve this same relief and reassurance now with epinephrine auto-injectors.
Second, as this shortage of EpiPens persists, consumers should have access to all epinephrine auto-injectors that are currently available and not in shortage. Unfortunately, many families are finding that when alternatives to the EpiPen are available, their insurance company does not cover the cost, forcing them to either pay entirely out of pocket or go without the product.
I implore you, on behalf of patients in
[1] RB letter to Gottlieb
[5] https://www.nbcnews.com/health/health-news/fda-extends-epipen-expiration-cover-shortages-n902656
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