• by Thom Forbes  @tforbes, August 17, 2018

The Food and Drug Administration yesterday approved two generic versions of Mylan’s EpiPen even as a shortage of the medication that treats severe allergic reactions has parents scrambling to replace expiring prescriptions as schools are beginning to reopen nationwide.

“The FDA Thursday authorized Teva Pharmaceuticals USA to sell generic versions of the EpiPen and EpiPen Jr for adults and children who weigh more than 33 pounds. The devices enable people to automatically inject the hormone epinephrine into the thigh when experiencing potentially life-threatening allergic reactions to bee stings, peanuts, drugs or other substances,” reports Rob Stein for NPR.org.

The EpiPen “touched off a furor two years ago over its price increases of 548% over about a decade,” Thomas M. Burton reminds us in the Wall Street Journal. “Mylan introduced its own half-priced generic version of the drug in 2016.”

“Mylan’s device has been plagued by periodic shortages, with consumers scrambling again in recent months to find a reliable supply,” writes Sheila Kaplan for the New York Times.

“Scott Gottlieb, the commissioner of the F.D.A., who had talked during his Senate confirmation hearing about planning to speed approval of some generic products to lower costs, said he was pleased with the timing,” Kaplan adds.

“We’re especially committed to the development of generic copies of complex products,” Gottlieb says in a statement following yesterday's decision. “These products can be hard to copy, and therefore sometimes don’t face timely generic competition once patents and exclusivities are no longer a block to approval.”

“Though the key ingredient in the EpiPen, epinephrine, has been available for decades and is no longer covered by a patent, generic copies of the device have struggled to reach the market because the product is technically a drug-device combination, and the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators,” reports CNBC’s Meg Tirrell.

“The FDA issued guidance in November 2017 to try to make it easier for generic copies of complex medicines like the EpiPen to reach the market, saying some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it’s intended,” Tirrell continues.

However, “it seemed doubtful that Teva would have the product ready for sale in the next few weeks when school begins. A company spokeswoman declined to say when it would be available, or how much it would cost,” the NYT’s Kaplan reports.

“We're applying our full resources to this important launch in the coming months and eager to begin supplying the market,” Teva spokeswoman Doris Saltkill tells Kaplan in an email.

Teva USA’s headquarters are in North Wales, Penn., but it announced last month that it will be moving to Parsippany-Troy Hills, N.J. Its parent company is based in Israel. Mylan’s international headquarters are in Canonsburg, Penn.

Meanwhile, EpiPen “and the authorized generic, two widely used allergic reaction treatments, as well as Amneal Pharmaceuticals’ generic auto-injector Adrenaclick, were added to the Food and Drug Administration’s drug shortage list in May. Another manufacturer, privately held Kaleo Inc., has not reported supply interruption,” writes MarketWatch’s Emma Court.

“All three companies have product available but ‘there may be occasional spot outages,’ FDA spokesperson Jennifer Dooren said. The regulator has been working with manufacturers and monitoring supply as the school year begins, she said,” Court adds.

“Mylan has faced competition from other autoinjectors — Impax Laboratories LLC’s Adrenaclick and Kaleo Inc.’s Auvi-Q — but neither are generic, which allows pharmacists to substitute the products for the brand-name version at the drugstore counter. The two rivals haven’t sold nearly as well as EpiPen without name recognition,” explains Bloomberg’s Anna Edney in Time. 

“We are concerned that the shortage has not gone away,” Jen Madsen, chief of staff and senior director of federal advocacy for the advocacy group Food Allergy Research and Education, tells MarketWatch’s Court. “We were certainly hoping it would be fixed by now, and it’s not, which is unfortunate.”

The nationwide shortage is affecting an unknown number of the six million kids — about two in every classroom — who require up-to-date doses of the medication, report Rachel Siegel and Carolyn Y. Johnson for the Washington Post. 

“Sales of the pens typically spike during the back-to-school season, as parents buy two-packs to leave at school and refill expiring prescriptions to keep in children’s backpacks or at home. Now many parents are heading to pharmacies for fresh medications to find that they are in short supply,” they write.