A group of US Senators is tightening the screws on Marathon Pharmaceuticals in the wake of the latest drug pricing scandal.
Just weeks after Marathon CEO Jeff Aronin managed to outrage a host of Duchenne muscular dystrophy families and Vermont Senator Bernie Sanders with his decision to price a cheap, generic steroid at $89,000 a year after finagling an FDA approval and some lucrative incentives specifically tailored to the disease, a group of US Senators has come together to step up demands for answers from the company about what it actually spent to prep this therapy for an approval.
“Marathon executives have defended the price of the drug,” the senators wrote, “arguing that other treatments for “orphan diseases” — those that affect fewer than 200,000 nationwide — cost more than $300,000. Marathon’s Chief Financial Officer has stated that Emflaza is “modestly priced for an orphan drug.” While this is true, orphan drugs for rare diseases are generally not old compounds that have been used to treat such rare disease for decades.
They added: “We are concerned that Marathon’s pricing unfairly exploits the DMD patient population and the FDA’s orphan drug incentives.”
This group includes seven Democrats, such as Patty Murray, Al Franken and Corey Booker, along with independent Angus King. And they followed up with a detailed list of questions about how much Marathon spent to develop deflazacort for the US market.
As I reported within days of the approval, Marathon’s boast about its extensive R&D effort — the “heavy lifting” needed to win over the FDA which would take years of marketing to cover — was thin camouflage for a relatively minor affair involving a group of preclinical and clinical studies that could be easily covered with the sale of the drug to a small part of the patient population for the past year.
The furor over deflazacort has focused new attention on how easy it is for biopharma companies to game the FDA in completely legal ways. In this case, Marathon took a steroid that’s been sold for around a thousand dollars a year to patients in countries around the world — as well as a number of patients and families in the US — and maneuvered it to an OK as an orphan drug, winning regulators’ approval and snagging a priority review voucher.
The last PRV was sold for $125 million just days ago and one fetched $350 million.
Pinned by critics as the latest profiteer to gouge patients, Aronin suddenly decided to “pause” the launch of deflazacort as he claimed that it was time to reflect on the price and consult with stakeholders. At the same time, the CEO went underground, refusing interviews and public appearances with Duchenne families.
The controversy arrived at precisely the worst possible time for the trade group PhRMA, which has been trying to distinguish its members from price gougers like the notorious Martin Shkreli, who outraged millions by jacking up the price of generic Daraprim by more than 5000%. But that’s exactly the same formula that Aronin used, and he’s currently a board member of PhRMA, which is spending tens of millions of dollars in a PR campaign aimed at winning over the public at a time that drug prices have come under intense scrutiny.
PhRMA CEO Stephen Ubl says the group is now reviewing terms for membership, and has suggested that Aronin may not be on the board for long.
The controversy around Marathon shows no signs of simmering down anytime soon, even while Aronin hunkers down in the face of a hurricane of criticism in Congress.
The CEO has refused multiple requests from me for an interview. I’ll leave it as a standing invitation, but I’ll be surprised if he ever responds directly.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 30,000+ biopharma pros who read Endpoints News by email every day.Free Subscription