Pharma, Policy

Now, the gloves are off in the EpiPen saga

The maker of EpiPen, the life-saving auto-injector for anaphylaxis, is under fire for exorbitant price hikes so much so that even Martin Shkreli called Mylan out for price-gouging last week.

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Physicians have joined the brouhaha over the soaring price of Mylan Pharmaceuticals‘ EpiPen.

As has been widely reported, Mylan has hiked the price of the life-saving auto-injector for anaphylaxis repeatedly in recent years. NBC News said the average wholesale price has gone up 461 percent, from $56.64 when Mylan bought the rights to the drug in 2007 to to $317.82 last year.

The retail price point now tops $600 for a two-pack, even though the dose of epinephrine inside costs about $1, according to Consumer Reports.

Adding fuel to the fire, it’s been revealed that Mylan CEO Heather Bresch has seen her total compensation go up by 671 percent in the same time frame, to more than $18.9 million in 2015. Bresch became CEO in 2012, though she has been a Mylan executive longer.

EpiPen  pulled down a 55 percent margin for the drug company in 2014 and accounted for 40 percent of Mylan’s operating profits that year, Bloomberg reported.

Oh, did we mention Bresch has some unique political connections? She happens to be the daughter of U.S. Sen. Joe Manchin (D-West Virginia).

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Mylan reportedly spent $4 million on lobbying in 2012-13 and was successful in getting the 2013 School Access to Emergency Epinephrine Act passed. That allowed public schools nationwide to stock EpiPens for student emergencies, sending sales higher.

Wednesday, the American Medical Association came out swinging, calling the price “exorbitant.” In a prepared statement, AMA President Dr. Andrew Gurman did temper his remarks beyond that one loaded word:

With Americans across the country sending their children back to school this month, many parents and schools are encountering sticker shock over the cost of EpiPens. Although the product is unchanged since 2009, the cost has skyrocketed by more than 400 percent during that period. The AMA has long urged the pharmaceutical industry to exercise reasonable restraint in drug pricing, and, with lives on the line, we urge the manufacturer to do all it can to rein in these exorbitant costs. With many parents required to buy two or more sets of EpiPens just to keep their children safe, the high cost of these devices may either keep them out of reach of people in need or force some families to choose between EpiPens and other essentials. The AMA will continue to promote market-based strategies to achieve access to and affordability of healthcare goods and services.

The AMA hasn’t responded to a request for clarification on what “market-based strategies” it thinks are appropriate in this case. MedCity News will update this story if we hear back.

But we know people are upset because even Martin Shkreli called Mylan out for price-gouging last week. “These guys are really vultures. What drives this company’s moral compass?” the indicted “pharma bro” told NBC News on Friday.

Conservative blogger and talk-show host Ed Morrissey on Wednesday compared Bresch to Shkreli, dubbing her “PharmaSis.”

Democratic presidential nominee Hillary Clinton also weighed in on Wednesday, calling EpiPen pricing “outrageous” and another “troubling example of a company taking advantage of its consumers.”

In a statement, Clinton continued:  “I believe that our pharmaceutical and biotech industries can be an incredible source of American innovation, giving us revolutionary treatments for debilitating diseases. But it’s wrong when drug companies put profits ahead of patients, raising prices without justifying the value behind them.”

Republican candidate Donald Trump has not yet opined on the EpiPen news.

Photo:  Freedigitalphotos.net user chainat