Amidst the ruckus of the impending presidential elections, the EpiPen and its increasing cost have recently come under fire. Highlighted by a recent New York Times article, the case of the EpiPen and its disgustingly high cost is nothing new. Almost annually, pharmaceutical executives discreetly increase the prices of a much-needed product only until Congress scolds the corporations, to which the typical executive “pleads innocence and gives as little information as possible.” However, if this pattern is indeed perennial, why has it continued to persist, especially when devices as medically critical as EpiPens have become unavailable to the masses?
To most, this question can be attributed to the legislature’s ineptitude in consistently regulating these pharmaceutical behemoths. Companies such as Mylan, the sole manufacturer of the EpiPen, strategically utilize lobbyists to ensure their interests are not only heard, but meticulously protected. In fact, as a result of Mylan’s indirect intervention into American politics, Mylan has “serendipitously” created a monopoly. Mylan’s EpiPen is still at an unfair advantage — with no legitimate competitor, it can rule the epinephrine market with ease. This monopoly finds its motivation primarily from the FDA’s inexplicable backlog of EpiPen alternatives, thus disallowing any EpiPen alternative from surfacing into the auto-injector epinephrine market. In fact, according to a recent NPR article, the backlog of decisions goes back four years, an unfortunate byproduct of the immense quantity of red-tape and bureaucracy that defines the Food and Drug Administration.
Furthermore, even if we keep Mylan’s monopoly out of the discussion, the EpiPen company reportedly may have violated antitrust laws through their EpiPen4Schools initiative, a cleverly disguised program that forces several schools to sign a binding contract to not purchase any products from Mylan competitors. Additionally, Mylan, in early 2015, reportedly filed a petition to lobby the FDA from allowing Teva, a rival pharmaceutical company, to sell EpiPens and undercut Mylan’s high prices.
Therefore, when Congress chastised Mylan for selling EpiPens at $608 a pop, it was simply the latest installment and representation of the battle between big business and the average American. Not only is the EpiPen’s market value around $600 for uninsured individuals, but it must be renewed annually at the same market value. Furthermore, even insured individuals will still pay a hefty co-pay for the EpiPen, all of which warrants immediate action to be taken upon Mylan and its exorbitant EpiPen prices.
There are several theoretical options to counteract the devastation that Mylan’s EpiPen monopoly has caused, though many of them may not be feasible. For instance, legislatures could impose a cap on the EpiPen market value, thereby prohibiting Mylan from selling these necessary medical devices at prices that many Americans simply cannot afford. However, this proposal would not only result in heavy backlash from big business in general (as it marks a dangerous precedent for other products), but it would also violate the spirit of capitalism that America holds dear. Similarly, legislature could invoke an investigation into the anti-trust violation that Mylan has allegedly caused. Yet, even if the New York Attorney General were to be successful in shutting down Mylan because of its violation of a federal law, the EpiPen market would be left with a dearth of viable alternatives, a potentially graver situation than the one we are currently in.
Therefore, in order to ensure EpiPens continue to service the millions of Americans who have allergies, Congress must put more resources into catalyzing greater efficiency in the FDA’s historically inefficient process of approving new products. These resources could consist of allocating more funds for the FDA’s oversight committee, thereby simply increasing the manpower of the review process or restructuring the review process itself to be more efficient. There is no guarantee that burgeoning products will find success in the market, but, just as Mylan was a fledgling company once, other companies like Teva and Adrenaclick can eventually promote competition in the EpiPen market to ultimately produce an affordable product for all who need it.
Sean Sequeira is a Viewpoint writer.
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