As the back-to-school season gets underway, the makers of EpiPen, an anti-allergy injector, are being blamed for shortages and – in a recurring complaint – exorbitant prices.
Sen. Richard Blumenthal, D-Conn., continued his long -running criticisms of Mylan, which markets the EpiPen at a press conference in Hartford on Monday, saying “the reason for its short supply is to keep prices up.”
“This lifesaving medicine is not available at many Connecticut pharmacies,” Blumenthal said.
While Mylan markets the EpiPen, Meridian — a unit of Pfizer — manufactures the injectors that are used to deliver an emergency antidote to severe allergic reactions to peanuts, bee stings and other substances that can trigger a life-threatening reaction known as anaphylaxis.
Blumenthal called the EpiPen shortages “a national scandal.”
Mylan shot back in a statement, saying that Blumenthal “held the exact same press conference on the exact same Monday in August one year ago.”
“Meanwhile, he and his colleagues have done nothing meaningful to address the real causes of rising drug prices,”’ the company said.
Meridian has been hit by a series of manufacturing problems in recent years and Mylan has recalled tens of thousands of the devices after complaints that some had failed to activate.
The U.S. Attorney’s Office for the Southern District of New York launched a civil investigation into the drug’s manufacturing in February, citing “alleged quality issues” at the Meridian plant in St. Louis, Mo. A number of deaths linked to faulty EpiPens that failed to release their epinephrine have been reported to the Food and Drug Administration.
There has been a scarcity of EpiPens since at least May 2018, when the U.S. Food and Drug Administration said the device was in short supply.
Pfizer noted there was a shortage of the life-saving injectors a year ago.
“Pfizer is working tirelessly to increase production and expedite shipments as rapidly as possible,” it said in a release dated August, 2018. “Currently, supplies will vary from pharmacy to pharmacy, and we cannot guarantee that product will be available at all pharmacies.”
Pfizer said that to address the shortage, the FDA had agreed to extend the one-year expiration date of the EpiPen by four months.
“Patients should have confidence in using the products from these particular lots as Pfizer works to stabilize supply, which is anticipated in the fourth quarter of 2018,” the drug company said.
Sen. Matt Lesser, D-Middletown, suffered an allergic reaction while attending a legislative reception last year at the state Capitol. The reaction was bad enough that it required the administration of epinephrine.
At the press conference with Blumenthal, Lesser said this is “a stressful time for parents” who need additional EpiPens to protect their children in the classroom and during after school activities.
Besides shortages caused by a “bottleneck” in the manufacture of the injectors, the price of EpiPens is often out of reach for many parents, Blumenthal said.
The cost of a two-injector pack of EpiPens jumped from $57 in 2007 to about $500 in 2016. That sharp price hike — which the company attributed to “improvements” in the product — drew public scorn and provoked Congress to hold a hearing on the issue in September of that year.
Mylan CEO Heather Bresch was grilled by both Democratic and Republican lawmakers who questioned whether individuals and states like Connecticut that pay millions of dollars for EpiPens through Medicaid are paying a fair price.
Rep. Jason Chaffetz, R-Utah, called EpiPen’s price hikes “extreme” and said Bresch’s testimony that Mylan makes only $50 in profit from each EpiPen is “hard to believe.”
In a statement released Monday, Mylan said its prices haven’t changed since 2016 and that more than 85 percent of epinephrine prescriptions are filled with “our authorized generic, which costs $300 for a two pack – the lowest available price on the market for an epinephrine auto-injector.”
Mylan also said it offers a patient assistance program to cover the full cost of the product for eligible patients and a $300 savings card.
The company conceded “it’s true the manufacturer of EpiPen, Meridian…continues to face supply challenges.”
“But as the senator knows, Mylan’s customer service team has located product for 100 percent of patients who have called our customer service line, including the senator’s constituents, at his office’s request,” the company said.
Blumenthal said Mylan is merely offering a “fig leaf” solution to the problem.
Teva Pharmaceutical, which already makes a generic EpiPen, began selling a version of Mylan’s EpiPen Jr. for young children last week.
Blumenthal said the generic injector “is still unavailable” to most who need it.
Lesser, who is chairman of the legislature’s insurance and real estate committee, said he is impressed with an Illinois law implemented last week that shifts the burden of paying for EpiPens for children 18 and younger from parents to insurance companies.
“We’re going to look at it very closely, “ Lesser said.
I find it very interesting to learn the following: “Pfizer said that to address the shortage, the FDA had agreed to extend the one-year expiration date of the EpiPen by four months.” Really? You mean for years we have been throwing away EpiPens after 12 months and buying new ones when in fact they would have been fine for 16 months? Or how long? Who benefits from the 12 month expiration date? The patient, or Pfizer? No one wants to risk the life of a loved one, or one’s own life, so we dutifully throw them away. But if they are actually good for 16 months, why haven’t we been told this long ago?