Poliquin hails FDA approval of first generic EpiPen devices

U.S. Rep. Bruce Poliquin (R-ME) commended recent action by the U.S. Food and Drug Administration (FDA), which on Aug. 16 approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injectors to treat life-threatening emergency allergic reactions in adults and children.

Rep. Poliquin has urged the FDA to allow for alternative and more affordable versions of the EpiPen devices, which he said should help alleviate costs for Maine’s rural emergency personnel.

“It’s critical we do everything we can to lower the costs for our rural emergency personnel and make these life-saving devices more affordable for them and for families across Maine,” Rep. Poliquin said.

Maine rural fire chiefs previously expressed their concern to the congressman about the rising costs of the devices, according to a statement from Poliquin’s office, and said they were challenged to balance the costs of maintaining sufficient EpiPen stocks with employee pay.

In 2016, the price of an EpiPen device increased over 500 percent compared to the previous decade, according to a letter Rep. Poliquin and more than 45 colleagues sent to the FDA that year. The lawmakers iterated “serious concerns about the near monopoly” held by the drug manufacturer, and called on the FDA to streamline the drug approval process to encourage competition, according to the Sept. 16, 2016 letter.

Last week, FDA Commissioner Scott Gottlieb tweeted that the FDA’s approval of “the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our commitment to making lower cost, safe, and effective generic alternatives available to patients.”

Eric Hargan, deputy secretary of the U.S. Department of Health and Human Services, noted on Aug. 21 in a tweet: “ICYMI: @SGottliebFDA has made increasing generic drugs approved by @US_FDA a priority. Put simply: more generics + more competition = lower drug prices for American Patients. After a record-breaking 1000+ generic approvals in ’17, FDA set another record w/ 126 approvals in July.”

“The approval of more affordable devices is welcome news, and I applaud the FDA in making this decision,” said Rep. Poliquin.

The FDA also said it is taking additional steps to “mitigate shortages of EpiPen (epinephrine) auto-injector by extending [the] expiration date for specific lots of medication,” according to several agency tweets this month.