What at first glance sounded like nothing but good news, the FDA’s approval of an Duchenne Muscular Dystrophy drug, has complicated undertones.
It was announced last week that Emflaza (deflazacort) was approved by the FDA. The steroid has already been used on a global scale for the treatment of DMD and patients in the USA have been importing it. The victory surrounding the approval of this drug has been undercut by a price hike.
The pharmaceutical company Marathon, is justifying the cost by the citing clinical trials that had to be conducted and stating that the price won’t be coming out of pocket but will be taken care of via health insurance. The CEO has stated that the higher cost will benefit the DMD community because profits will be reinvested into further research.
Critics are saying that Marathon is abusing the 7-year market exclusivity it received with the orphan drug designation. Why should American patients pay $89,000 annually for a drug available globally for $1,000? The manufacturing costs are relatively inexpensive for its current production in places like the UK and Canada. Marathon has cited that this approval make the drug more widely available, but some say this approval will force patients who are already obtaining the drug cheaply elsewhere to impact their insurance premiums by receiving the steroid through Marathon.
Among the critics are Senator Bernie Sanders and Rep. Elijah Cummings. The public outcry over the price of the drug has prompted Marathon to temporarily halt the roll out of the drug.