Martin Shkreli, who became famous overnight back in 2015 for raising the price of Daraprim 5000%, is back in the headlines. Tagged the “pharma bro” for the cavalier attitude he fronted about his greed, Martin is actually currently behind bars. No, not for raising a drug price – otherwise the jails would overflow with pharma execs – but for financial fraud related to his work as hedge fund manager.
That’s old news.
Now, years later, Shkreli, the company Vyera Pharmaceuticals (formerly Turing Pharmaceuticals) and his colleague, Kevin Mulleady, are being charged by the Federal Trade Commission and NY State Attorney General Letitia James. With what? Pasted from the AG’s press release:
Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug
Basically, the charge is that the Vyera took myriad actions to prevent a lower-cost generic drug from coming to market. But I’m going to stop there and not dive into the minutiae of this case to bring up something highly relevant that seems to have vanished.
What ever happened to the original drug importation plan put forward by the Secretary of the Department of Health and Human Services, Alex Azar, to allow for the importation of single source drugs, like Daraprim? Azar’s initial importation plan would have concretely helped curtail future Pharma Bro maneuvers like Shkreli’s. It called for making it legal to import foreign versions of “single source” and off patent drugs, with Daraprim being the prime example.
Here’s what Azar had to say in an HHS press release from 2018:
“We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent… Safe, select avenues for importation could be one of the answers to these challenges.”
In fact, PharmacyChecker.com’s CEO, Tod Cooperman, MD, published an article in the Huffington Post back in 2015 to let the public know that Daraprim, made by GlaxoSmithKline in the European Union, was available for about $6/pill on the day Martin raised it to $750. For those Americans who might have been caught needing Daraprim and unable to afford it, Daraprim was available to order from the UK for a 99% discount.
Sure enough, Daraprim today costs over $750/pill with a discount card in the U.S. but it’s now apparently down to $1.33/pill in the UK.
I don’t believe that Secretary Azar came up with this plan first. For example, the single source drug importation plan was put forward in 2017 by Dr. Aaron Kesselheim, MD from Harvard and Thomas J. Bollyky, JD, from the Council on Foreign Relations 2017. See Can Drug Importation Address High Generic Drug Prices? But this idea is no where to be found in the current drug importation proposals of the Trump administration.
The Trump administration’s current drug importation plan seeks to operationalize Section 804 of the Food, Drug and Cosmetic Act to permit states to run wholesale drug importation programs – importing from Canada only, called Pathway I. That would not include GlaxoSmithKline’s really cheap Daraprim from the EU. Known as Pathway II, drug companies may be able to import their own drugs at a lower price, but only if they want to! And only if the drug is proven to be the exact same FDA-approved drug. Would that include Glaxo’s Daraprim? It might but I don’t think so because only Vyera, not Glaxo, has marketing authorization to sell Daraprim in the U.S.
So, go ahead and make Martin more of a punching bag and poster boy for pharmaceutical greed. It will be great for political point scoring, and the scrutiny into how drug companies block generics could be useful down the road. But, even better: make it expressly legal to import Daraprim at a 99% discount.
