A drug maker’s plans to charge $89,000 for a drug that fights a rare disease that primarily affects young boys is getting major heat from lawmakers.
Sen. Bernie Sanders, I-Vt., and Rep. Elijah Cummings, D-Md., sent a letter Monday to Marathon Pharmaceuticals saying they were infuriated about the company’s price for Emflaza. The Food and Drug Administration approved the drug last week to treat the rare disease Duchenne’s muscular dystrophy, and soon after reports emerged of a plan to charge $89,000 per year for it.
Emflaza has been on the market for decades as a steroid and costs about $1,000 a year in Canada and the United Kingdom. It had not been approved by the FDA as a steroid.
The lawmakers say they are worried that Marathon will have a monopoly on Emflaza because it was approved under the FDA’s Orphan Drug Program, which gives seven years of market exclusivity to drugs that treat rare diseases.
The orphan drug program is meant to encourage research into new treatments for rare diseases and not to “provide companies like Marathon with lucrative market exclusivity rights for drugs that have been available for decades,” the letter said.
Marathon, which did not return a request for comment, isn’t new to congressional ire.
The two lawmakers, who have investigated other spikes in pharmaceutical prices, wrote to Marathon in 2014 to investigate the price increases of heart drugs Isurpel and Nitropress. Marathon sold the drugs to Valeant, which was brought before Congress to answer for the high prices.
“We remain gravely concerned about these recurring abuses in the pharmaceutical industry,” the letter said.
Cummings and Sanders want Marathon to answer a list of questions behind the price hike, such as costs for the development and approval of it and the acquisition history.
They also want full estimates for total revenue and profits for future drug sales.
Meanwhile, Sen. Chuck Grassley, R-Iowa, want to know more about the orphan drug program and how it may contribute to prices.
He said Senate staff is working to understand “the extent of the problem and how we might fix it.”
They are the latest missives from lawmakers over high drug costs. Earlier this month more than 30 senators said they wanted answers on why an auto-injector version of the overdose antidote naloxone had spiked to $4,500.
President Trump has said he wants reforms to improve high drug prices, including giving Medicare the power to negotiate for lower drug prices and reforming the FDA to get drugs approved faster and spur competition.
However, no legislation has been introduced to give Medicare the power for those negotiations.
The House Energy and Commerce Committee will take up a bill this week that gives incentives to drug makers to make generics that are in short supply or lack competition.
