The New York Times reports that the Food and Drug Administration (FDA) has accused Pfizer of failing to address complaints about malfunctioning EpiPens, used to prevent serious allergic reactions. Hundreds of people are reporting that EpiPens have killed or harmed them because of a malfunction in its drug delivery mechanism. Does Pfizer care about malfunctioning EpiPens?
Pfizer owns the patent on the EpiPen’s delivery system. The delivery system is supposed to ensure that people get the proper dose of epinephrine. That dose prevents a serious allergic reaction. If it does not work, people’s lives can be at risk.
Pfizer claims that people who report being harmed may not have used their EpiPens properly. They are not medically trained. Needless to say, EpiPens are designed so that you do not need to be medically trained to operate them.
Pfizer further claims that people cannot prove a “causal” link between a death and the malfunction of the EpiPen. However, after FDA intervention, including inspection of the manufacturing plant and many discussions, Pfizer did recently recall 13 lots of the EpiPen because of device malfunction in its drug delivery mechanism.
The EpiPen has been in the spotlight this past year because of its steep price hike, as Steven Findlay reported for Just Care back in August 2016. Mylan, which manufactures the EpiPen, increased its list price almost fourfold to $608 from $165 five years earlier. The drug it dispenses is a generic, which costs almost nothing to manufacture.
Both the malfunction and the cost of the EpiPen are two of thousands of reminders that the pharmaceutical marketplace is dysfunctional, non-competitive, and unsustainable. Everyone of us pays the price for the dysfunction, in higher insurance premiums and higher taxes. And people who use the drugs, as well as their loved ones, suffer all the more.
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