Washington, DC — Michael Rosen reports on TechPolicyDaily.com that it’s supposed to be success that has many fathers and failure an orphan, but the EpiPen debacle can trace its lineage to multiple ancestors.
For those living under a rock the last few weeks, the lifesaving auto-injector device, which delivers epinephrine to those whose severe allergies spark anaphylaxis and which sold for under $100 in 2009, has spiked in price to $600 as EpiPen manufacturer Mylan Pharmaceuticals finds itself controlling 94 percent of the epinephrine device market.
This unusual jump has unleashed fury across the political spectrum, with Hillary Clinton calling it “outrageous,” Senator Richard Blumenthal (D-CT) blasting Mylan’s “virtual monopoly.”
Also, Senate Judiciary Chairman Charles Grassley (R-IA) writing the company’s CEO to express his “significant concern” about the “unsafe situation.”
In response, Mylan has struggled to reassure the public by noting that few patients pay the full retail price for the auto-injectors and by offering rebates of up to $300 for some individuals.
So what’s behind this unusual jump? How did the market for epinephrine delivery break down so completely?
For those living under a rock the last few weeks, the lifesaving auto-injector device, which delivers epinephrine to those whose severe allergies spark anaphylaxis and which sold for under $100 in 2009, has spiked in price to $600 as EpiPen manufacturer Mylan Pharmaceuticals finds itself controlling 94 percent of the epinephrine device market.
This unusual jump has unleashed fury across the political spectrum, with Hillary Clinton calling it “outrageous,” Senator Richard Blumenthal (D-CT) blasting Mylan’s “virtual monopoly.”
Also, Senate Judiciary Chairman Charles Grassley (R-IA) writing the company’s CEO to express his “significant concern” about the “unsafe situation.”
In response, Mylan has struggled to reassure the public by noting that few patients pay the full retail price for the auto-injectors and by offering rebates of up to $300 for some individuals.
So what’s behind this unusual jump? How did the market for epinephrine delivery break down so completely?
Missteps from regulators and drugmakers
The Food and Drug Administration deserves some of the blame for the fiasco, as its lead-footed regulation has stifled the availability of alternatives to EpiPen.
For instance, Teva Pharmaceuticals, one of the world’s largest generic drug manufacturers, has worked for years to develop an alternative auto-injector and expects to put one on the market next year.
But the company’s efforts were rebuffed by the FDA early this year, which cited unspecified “major deficiencies” in Teva’s product.
And in 2012, the agency withheld approval of Sanofi-Aventis’s Auvi-Q until the company changed the name of the epinephrine device from “EpiCard” and “e-cue.”
Drugmakers also deserve some of the blame. Sanofi had to recall Auvi-Q last October after misdosing the delivery units. A product called TwinJect was also recalled back in 2010.
The role of IP
But in addition to these follies, various forms of intellectual property have played important roles in the story.
First, while the patents for epinephrine itself expired decades ago, and while the drug itself costs roughly ten cents per dose to produce, Mylan and its predecessors have zealously guarded the innovations behind the pen used to deliver the medicine.
For instance, Meridian Medical Technologies, which now licenses the EpiPen to Mylan, waged a years-long patent battle against Sanofi to keep Auvi-Q off the market, not settling the case until 2012.
Still, as some observers have noted, EpiPen was protected by the same patents in 2007 as it is now, and back then it sold for under $60.
But the trade name of the device also plays an important role. As one doctor-blogger explains, while doctors can write prescriptions for brand-name drugs and have pharmacists fill them with generics, if a doctor writes a script for EpiPen the pharmacist must provide an actual, brand-name EpiPen, since the injector itself is regulated as a medical device.
Thus, while not precisely a trademark issue, the powerful brand equity Mylan has built through its trade name IP may cause doctors to prescribe only the EpiPen in place of cheaper alternatives.
Finally, the intersection of IP and regulatory issues has contributed to Mylan’s market control.
For example, earlier this year San Diego-based Adamis Pharmaceuticals sought to circumvent Mylan’s patents by simply selling pre-dosed epi-filled syringes that patients could use to inject themselves.
But the FDA rejected Adamis’s application, requiring it to expand its patient usability study and stress-test its product more thoroughly.
Thus, the winds of regulatory and IP issues have gathered force and created a perfect storm that patients are now forced to weather. Here’s hoping it clears up soon.
The Food and Drug Administration deserves some of the blame for the fiasco, as its lead-footed regulation has stifled the availability of alternatives to EpiPen.
For instance, Teva Pharmaceuticals, one of the world’s largest generic drug manufacturers, has worked for years to develop an alternative auto-injector and expects to put one on the market next year.
But the company’s efforts were rebuffed by the FDA early this year, which cited unspecified “major deficiencies” in Teva’s product.
And in 2012, the agency withheld approval of Sanofi-Aventis’s Auvi-Q until the company changed the name of the epinephrine device from “EpiCard” and “e-cue.”
Drugmakers also deserve some of the blame. Sanofi had to recall Auvi-Q last October after misdosing the delivery units. A product called TwinJect was also recalled back in 2010.
The role of IP
But in addition to these follies, various forms of intellectual property have played important roles in the story.
First, while the patents for epinephrine itself expired decades ago, and while the drug itself costs roughly ten cents per dose to produce, Mylan and its predecessors have zealously guarded the innovations behind the pen used to deliver the medicine.
For instance, Meridian Medical Technologies, which now licenses the EpiPen to Mylan, waged a years-long patent battle against Sanofi to keep Auvi-Q off the market, not settling the case until 2012.
Still, as some observers have noted, EpiPen was protected by the same patents in 2007 as it is now, and back then it sold for under $60.
But the trade name of the device also plays an important role. As one doctor-blogger explains, while doctors can write prescriptions for brand-name drugs and have pharmacists fill them with generics, if a doctor writes a script for EpiPen the pharmacist must provide an actual, brand-name EpiPen, since the injector itself is regulated as a medical device.
Thus, while not precisely a trademark issue, the powerful brand equity Mylan has built through its trade name IP may cause doctors to prescribe only the EpiPen in place of cheaper alternatives.
Finally, the intersection of IP and regulatory issues has contributed to Mylan’s market control.
For example, earlier this year San Diego-based Adamis Pharmaceuticals sought to circumvent Mylan’s patents by simply selling pre-dosed epi-filled syringes that patients could use to inject themselves.
But the FDA rejected Adamis’s application, requiring it to expand its patient usability study and stress-test its product more thoroughly.
Thus, the winds of regulatory and IP issues have gathered force and created a perfect storm that patients are now forced to weather. Here’s hoping it clears up soon.
