Pittsburgh Post-Gazette

Sticking those in need

A new generic will end EpiPen gouging

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Long before it became the symbol for outrage over pharmaceut­icals taking advantage of vulnerable consumers, the EpiPen was a vital lifesaving device for people with severe allergies.

The brand-name personal epinephrin­e auto-injector is a must-have to treat lifethreat­ening reactions in people with allergies to bee stings, nuts and other substances.

Mylan bought EpiPen in 2007 and proceeded to hike prices by 600 percent, prompting public outrage over gouging consumers in life-ordeath situations. The company began offering coupons to help make the devices more accessible, but that only dropped the cost for a pair of pens from $600 to $300 — hardly affordable.

The company was forced to pay a $465 million settlement to the U.S. Justice Department over claims it overcharge­d the government for EpiPens.

Next, shortages of the EpiPens earlier this year made the devices hard to find at any price. Mylan blamed the shortages on manufactur­ing problems, but that was little help to families whose children need to carry the devices to school.

If a single company can control access to lifesaving medicine, where can consumers turn when that company can’t make enough of that medicine available? Or keep its price within reach?

When he was nominated to head the Food and Drug Administra­tion in 2017, Scott Gottlieb told the Senate that one of his priorities would be to speed up approval of generic versions of drug products, a process that often makes dramatical­ly less expensive versions of drugs available to consumers.

Earlier this month the FDA approved a generic version of the EpiPen, which is to be made by Teva Pharmaceut­icals USA. Once it reaches pharmacies, customers will have access to the lifesaving drugs they need at lower cost.

Market pressure from generic copies has made myriad prescripti­on drugs more affordable. In this case, the generic approval seems likely to address dangerous shortages too.

The release of a generic version of EpiPen holds great promise for the many Americans who rely on the devices to treat potentiall­y deadly allergic reactions. And it is also good news for all Americans who need a more responsive FDA and quicker approval of less-expensive generic drugs — all of us.

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