Jennifer Madsen, head of federal advocacy for the Food Allergy Research & Education advocacy group based in Virginia, said about 15 millions Americans, including six million children, have food allergies. Of those, Ms. Madsen estimated that potentially 2.4 million children have had a life-threatening incident. Her organization has been pushing the F.D.A. to approve a generic EpiPen for a long time.
“We’re very excited to have this big win for the food allergy community,” she said. “Particularly in view of this national shortage.”
In May, after scores of consumers reported that they couldn’t buy EpiPens, the F.D.A. announced there were shortages of two types of epinephrine auto-injectors, including Mylan’s EpiPen, and Adrenaclick, made by Impax Laboratories. The agency attributed the shortages to manufacturing problems.
Another brand, called Auvi-Q, was available, but was not covered by as many insurance policies.
The EpiPen has had a troubled history.
And Mylan itself, stung by congressional inquiries and criticism, released its own generic version that costs about half as much. In August of last year, Mylan announced that it had finalized a $465 million settlement with the Justice Department about claims that it overcharged the federal government for the product.
Last September, the F.D.A. accused the drugmaker Pfizer, which manufactures the EpiPen for Mylan, of failing to properly investigate reports of EpiPen malfunctions, including cases in which patients became severely ill or died after the device did not work. An F.D.A. warning to Pfizer said that Meridian Medical Technologies, which is a unit of the drug giant, did not adequately examine problems with a critical component of the EpiPen, the mechanism that insures that it fires and delivers the proper dose.
At the time, a Pfizer spokeswoman said the company was confident in the EpiPen’s safety and efficacy, and said it had no information to indicate that there was any causal connection between the product complaints and any patient deaths.