By Henry Ehrlich
“It’s good to be the king,” says Mel Brooks, playing Louis XVI in The History of the World, Part 1 while leering at the decolletage of a willing lady of the court. This came to mind as EpiPen picked up where it left off last season infuriating patients, parents, and legislators for the privileges that attach to its near-monopoly status. Rules of the marketplace that have affected a long line of competitors don’t seem to apply to EpiPen.
Last week, the New York Times reported that the Food and Drug Administration accused Pfizer, which manufactures EpiPen for Mylan, “of failing to properly investigate reports of malfunctioning EpiPens, including incidents when patients died or became severely ill after the device failed to work.”
Pfizer spokeswoman, Kim Bencker, responded that the company was confident in the safety and efficacy of the 30 million EpiPens sold since 2015.
A few comments:
1) Without sympathy for Mylan, I would like to see some substantiation of those deaths. Fatal anaphylaxis is rare enough, and food allergy is the rarest cause. Most of those fatalities result from delayed use of epinephrine, but some happen with timely use. Maybe some of those can be attributed to misfiring EpiPens, but there’s nothing in the news coverage to indicate that’s the case.
2) It is irksome to Auvi-Q fans that their favored product was completely withdrawn because of a putative manufacturing flaw and they were compelled to return to EpiPen for two years. By comparison, the Times says that Pfizer and Mylan recalled 13 lots of EpiPen this year only after the F.D.A. inspected the suspect manufacturing facility, but production and sales continued. When Auvi-Q went away, EpiPen was a “safe” reserve. What do people do now when EpiPen’s safety is called into question? The newly revived Auvi-Q is showering the market with affordable injectors, but do they have the capacity to replace EpiPen while Mylan gets its act together?
3) My third complaint derives from an additional comment by the Pfizer spokesperson, Kim Bencker. “It’s not unusual to receive product complaints, especially when the product is frequently administered by non-medically trained individuals.” Way to go–blame the customer. In light of those complaints, shouldn’t EpiPen undertake much wider efforts to instruct patients and caregivers in the proper use of the device?
Fast forward a week and we have another nasty report on EpiPen, unconnected to the FDA story, this one from STAT as part of an article about big pharma tactics to maintain monopoly status as their patents wind down. That is the point where generics and competition theoretically come into play. (We have covered this before on this website as it pertains to antihistamines.)
STAT tells us, “EpiPen falls under a category called complex generics, which covers a host of products including drug-device combinations. Mylan, EpiPen’s manufacturer, has spent years tinkering with its injector pen to make it easier to safer and easier to use. And because each change is duly patented, the net effect is a product with virtual immortality.”
The drawback for competitors is that with complex generics, “…in order for the FDA to consider a competitor to be truly interchangeable, a patient must be able to use it without additional training. This creates a paradox: How do you make something that works exactly like an EpiPen but doesn’t infringe any of EpiPen’s patents?” Sneaky.
Two scandals, one mechanical, one legal, with no apparent connection? Maybe not. Maybe all that tap dancing to stay one step ahead of patent expiration is also outpacing their ability to manufacture a consistently dependable product. Perhaps it is time to put more money into mechanical engineering and less into legal engineering.
The ideal, of course, would be a new autoinjector with Auvi-Q’s cool but at a much lower cost. The current competitive environment favors EpiPen, with its massive market share. It reminds me of the old AT&T, which tolerated only as much competition as it needed to keep it out of the clutches of antitrust enforcement. Or the old IBM, which chose to concentrate on building personal computers and outsourced building the operating system to Bill Gates. We need some disruption in the autoinjector market. Everyone hates EpiPen, but they often have to keep it with them at all times. If something really new (and cheap) arrives, monopoly EpiPen will age faster than the face of Dorian Gray.