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Morning Briefing

Summaries of health policy coverage from major news organizations

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Friday, Aug 26 2016

Full Issue

A Monopoly, FDA Oversight And Other Factors That Contributed To The EpiPen Controversy

Reports put the ongoing fracas over the soaring price tag of this emergency allergy medication into context by detailing a range of factors including why EpiPens are not reusable and legal challenges related to price gouging.

EpiPen’s rising price is particularly notable because state and federal legislation have been key to the drug’s rapid growth. Annual prescriptions for EpiPen products have more than doubled in the past decade to 3.6 million, according to IMS Health data. Mylan benefited from factors including failed competitors, patent protections and laws requiring allergy medications in schools. Having a virtual monopoly has facilitated the rapid price hike. Mylan reached $1 billion in sales for the second time last year. (Johnson and Ho, 8/25)

While anger is directed at Mylan Pharmaceuticals over the rising cost of its EpiPen device, some lawmakers wonder whether the US Food and Drug Administration should share some of the blame for the high prices paid by consumers. How so? They want to know if the agency made it possible for Mylan to dominate the market and charge whatever price it wants. (Silverman, 8/25)

The controversy surrounding skyrocketing prices over the EpiPen emergency allergy shots has nothing to do with what's in the devices. That's the 100-year-old chemical epinephrine, which costs just pennies. It's the device that Mylan is charging so much for. So why not replace cartridges of epinephrine that have expired with new ones? (O'Donnell, 8/25)

As the makers of EpiPen battle a firestorm surrounding price increases, a new federal lawsuit seeking class-action status argues that the company is engaging in price gouging by forcing consumers to buy the pens in packs of two. The lawsuit was filed Tuesday in the Eastern District of Michigan on behalf of six EpiPen purchasers, three of them based in Michigan. It says there is little evidence doctors ever recommended the pens be sold in packs of two — and yet by 2011, EpiPen’s maker Mylan did just that. (Bethencourt, 8/25)

Mylan Pharmaceuticals has come under intense fire for massive price hikes of EpiPens over the last week, facing scrutiny from lawmakers and industry groups. It is less well known, however, that while Mylan markets and prices the drug, Pfizer Inc. actually manufactures the drug and has seen increased revenues from EpiPens over the last few years. The financial relationship between the two drug companies is unclear, and Pfizer declined to elaborate. Mylan did not respond to a request for further comment about EpiPens or how the two companies divide revenues. (Owens, 8/26)

In addition, news outlets also offer timelines and background on rising costs of this drug and others that came before it -

The firestorm over steep price increases for the EpiPen — which can rescue people having life-threatening allergic reactions  — is just the latest in a long line of controversies over high prescription drug prices. A decade ago, much of the concern over prescription drug prices involved new high-tech cancer drugs, used by only a few thousand patients a year. In recent years, the prices for decades-old generic drugs have soared, as well, as pharmaceutical companies purchase the rights for drugs with no competition. Here's a recap of some of the most eye-popping prices. (Szabo, 8/25)

Outrage over the massive EpiPen price hike feels like deja vu. A year ago, America was in shock when a drug called Daraprim that's used by some AIDS and transplant patients skyrocketed overnight from $13.50 to $750 a pill. ... Hillary Clinton tweeted that the 5,000% spike was "outrageous" and amounted to "price gouging." Nothing about the drug itself had changed except this: a new company -- Turing Pharmaceuticals -- had bought the rights to distribute it. The Daily Beast dubbed Turing's CEO "the most hated man in America." (Long, 8/25)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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