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Regulatory News | 13 February 2017 | By Zachary Brennan
Sen. Bernie Sanders (D-VT) and Rep. Elijah Cummings (D-MD) on Monday wrote to Illinois-based Marathon Pharmaceuticals CEO Jeffrey Aronin, calling the company’s plan to charge $89,000 annually for its recently approved treatment “outrageous.”
Not only did Marathon not develop the steroid, known as Emflaza (Deflazacort) and approved by the US Food and Drug Administration last week to treat Duchenne Muscular Dystrophy, but the letter notes that the steroid is currently available in the EU and Canada for about $1,000 per year.
“We believe Marathon is abusing our nation’s ‘orphan drug’ program, which grants companies seven years of market exclusivity to encourage research into new treatments for rare diseases – not to provide companies like Marathon with lucrative market exclusivity rights for drugs that have been available for decades,” Sanders and Cummings write. Their concerns with Marathon's gaming of the orphan drug system come as Sen. Chuck Grassley (R-IA) said Friday he would look into ways the Orphan Drug Act have been abused.
In addition to winning these incentives for bringing the older treatment to the US market as an orphan drug, Marathon also won a lucrative priority review voucher, which have sold for as much as $350 million.
By 27 February, Sanders and Cummings are seeking the following documents and information from Marathon:
Tags: Marathon, Emflaza, Deflazacort, steroid, DMD