Just like earlier this year with Martin Shkreli and Daraprim, the Internet is full of outrage the past few days over the action of Mylan CEO Heather Bresch to raise the price of the live-saving drug EpiPen to $500 per unit. And as always happens, politicians are getting into the act, particularly Hillary Clinton, who raged that Mylan must reduce the price immediately – as if pharmaceutical companies check with candidates for political office in setting their pricing.
But if Hillary really wants to manifest her rage – as if it were anything but calculated for her own benefit – she should turn it inward toward herself and the Democratic Party. Because everything about this can be traced back to Democrats.
Let’s start with the fact that Bresch is the daughter of U.S. Senator Joe Manchin (D-West Virginia). That makes it a little awkward for the denizens of Washington to haul her in front of congressional committees for a grilling on her greed, you think? But the truly uncomfortable truth for Democrats is that the EpiPen price spike is not so much the product of “greed” as it is the product of one company having a monopoly. And that the direct result of the Democrat-controlled Food and Drug Administration’s persistent refusal to allow anyone to compete with Mylan in the sale of EpiPen, as the Wall Street Journal explains:
Thus EpiPen should be open to generic competition, which cuts prices dramatically for most other old medicines. Competitors have been trying for years to challenge Mylan’s EpiPen franchise with low-cost alternatives—only to become entangled in the Food and Drug Administration’s regulatory afflatus.
Approving a generic copy that is biologically equivalent to a branded drug is simple, but the FDA maintains no clear and consistent principles for generic drug-delivery devices like auto injectors or asthma inhalers. How does a company prove that a generic device is the same as the original product if there are notional differences, even if the differences don’t matter to the end result? In this case, that means immediately injecting a kid in anaphylactic shock with epinephrine—which is not complex medical engineering.
But no company has been able to do so to the FDA’s satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.
Then in February the FDA rejected Teva’s generic EpiPen application. In June the FDA required a San Diego-based company called Adamis to expand patient trials and reliability studies for still another auto-injector rival.