Marathon’s major misstep shows that drug pricing debate is here to stay

pharmafile | February 14, 2017 | News story | Manufacturing and Production, Sales and Marketing Duchenne Muscular Dystrophy, Emflaza, marathon 

Marathon Pharmaceuticals’ approval, last week, by the FDA for its treatment for Duchenne muscular dystrophy would usually have been cause for celebration within the pharmaceutical company and more than likely it was – but only for the weekend. Starting on Monday morning, the price of the treatment started hitting the headlines and suddenly Marathon was experiencing a hangover to the party rather than sooner than they would have hoped.

The reason the price of the treatment has taken over headlines is because, at $89,000 per year, the treatment is incredibly expensive. Not only this, because there were no alternative treatments, those, or those responsible for those, suffering from Duchenne muscular dystrophy could import the drug into the US for a fraction of that previous figure, at $1,000. However, as the only approved treatment now on the market, patients will no longer be able to import and will have to switch to Marathon’s Emflaza to continue treatment.

The reaction to the news is symptomatic of the new era of drug pricing within the US, and more broadly across the globe, that public anger at drug pricing is hitting pharmaceutical companies and hitting them hard. The reaction to this particular incident shows that the pricing debate is persistant and actually gaining power. The outcry has forced Marathon to pause the commercial release of the drug as it scrambles to firefight the negative PR that has erupted over its proposed pricing.

In an “Open Letter to the Duchenne Community”, Marathon has attempted to address the debate: “There is confusion that this is a generic drug. In the United States, FDA considers deflazacort a new drug and we had to get it approved. Our tablets are manufactured in the United States. The resources we invested were substantial and we don’t expect to recoup our investment for several years and we have only 7 years of market exclusivity. If we are profitable, we are committed to re-investing our earnings from Emflaza into additional research into Duchenne.”

It’s unlikely that Marathon’s smoke-and-mirrors approach to the truth is likely to help matters – though the FDA does regard it as a new drug, it has been around for years and patients have been importing the same medicine into the US for decades. On top of this, seven years market exclusivity for the drug is standard from the FDA for drugs of its type – citing this as a reason to charge a high price does not tally with its argument.

The decision to pause the release of the drug is significant – it shows that public anger and media coverage are now at sufficient levels to both catch a company by surprise in its intensity and also force them into retrospective action. There’s no doubt that other pharmaceutical companies will now watch the release of the drug very closely and will have to engage, in one way or another, the drug pricing debate – especially as it seems to be gaining momentum and influence.

Ben Hargreaves

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