September 12th, 2016
EpiPens Should Be Less Expensive
This basic lifesaving medication is cheap to produce. It should not be a way to make a billion dollar profit. Should EpiPens be inexpensive and available? I say yes, and here are my reasons. I am not going to blame Shkreli or Bresch for trying to make money; it’s the system of silence and inaction that I blame. Money, power, corruption, and political influence are the key factors that allow big pharma and the individuals who run them to get free publicity and millions of dollars in their pockets.
Remember Shkreli’s arrest? He posted bail of $5 million within 24 hours. Yeah, the same guy who drove the price of Daraprim from $13.50 to $750 a pill had no problem coming up with $5 million in a day. Surprising? No.
Currently, Shkreli’s company, Turing Pharmaceuticals, makes the only FDA-approved pyrimethamine to treat toxoplasmosis. Even though the patent expired long ago, any company who wants to make a generic would need considerable time to go through FDA’s approval process. Silence and inaction on drug reform mean that patients are now charged 50 times more for their medication.
When Bresch’s company, Mylan, first bought Epipen in 2007, the price was around $50 for a single pen. Now, it has climbed to $600 for a pack of two! Epinephrine is not a new drug. It was first isolated in 1901, and it is not under patent. It is on the WHO list of essential medications, and the wholesale cost in the developing world is between US$0.10 and US$0.95 a vial. In Canada, Epipens cost around $102 (American) dollars, because Canada regulates drug prices.
The Epipen autoinjector is patented. But, how much does it cost to make an autoinjector? I mean, it is not made of gold or platinum! Now, Mylan promises a cheaper generic for the U.S. market. This is the recent trend in pharmaceuticals — to raise prices (“temporarily”) with a promise of a future generic. Everyone quietly pays the “temporary” higher price, because “the generic is coming.”
However, the FDA takes a long time to approve generic medications and devices. Teva failed to obtain regulatory approval for its epinephrine-delivery device, and Sanofi recalled its autoinjector for incorrect dosage delivery. So Mylan alone sells Epipens and can increase the price without any competition. One might say that this is exploitation of a basic human need to obtain a life-saving medication — a medication that has been produced for almost 100 years.
Drug and device patents allow monopolies in the pharmaceutical industry: An average patent is enforced for 12 to 15 years. Although drug regulation obviously is important for patient safety, drug prices should be regulated, and approvals of generics should be prioritized. Right now, federal law prohibits Medicare from negotiating drug prices. We need legislation that limits the ability of pharmas to manipulate the system.
There is no transparency in the drug manufacturing costs, and a recent analysis, reviewed by NEJM Journal Watch, suggests that development costs do not explain the costs of patent drugs (Why Do Prescription Drugs Cost So Much?). In reality, the silence and inaction around drug pricing allows pharmas to charge “whatever the market will bear.” It is unfair to the general public, because medicine is not a choice, but a need. Silence and inaction are unacceptable responses.