- After backlash from the public and Congress alike, industry trade group PhRMA is joining the chorus of frustrated voices about Marathon Pharmaceutical’s high pricetag for an old steroid.
- PhRMA put out a statement Wednesday evening praising Marathon’s latest decision to hold off on the launch of its recently approved Duchenne muscular dystrophy (DMD) drug.
- The trade group also said it is currently reviewing the status of Marathon as a member of the industry group. "Their recent actions are not consistent with the mission of our organization," PhRMA president and CEO Stephen Ubl said.
Marathon Pharmaceuticals added to still-raging firestorm over drug pricing by setting the list price of Emflaza (deflazacort), an old steroid, at the steep price of $89,000 per year.
The drug, which was approved by the Food and Drug Administration last week for DMD, has long been available in other countries for less than a $1,000 per year and is frequently used off-label to treat the muscle-wasting disease. Deflazacort had never been approved in the U.S., though, nor approved to treat DMD in any jurisdiction before last week.
Marathon has contended that patients would never pay the list price of $89,000 due to insurance, rebates and discounts, as well as patient assistance program.
The company also drew on the standard pharma playbook for defending prices, pointing to its R&D costs it paid to gain FDA approval.
Yet, the work Marathon did was far from innovative. The biotech licensed rights to old data and carried out an array of preclinical and clinical studies testing drug-drug interactions and other side effects, but did not conduct any more pivotal trials.
Marathon's move does not fit with the innovative, science-driven image that PhRMA has been trying to project over the last several months, eventually triggering a response from the group.
"The leadership of the PhRMA Board of Directors has begun a comprehensive review of our membership criteria to ensure we are focused on representing research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients," said Ubl in an emailed statement.
PhRMA has been combating a poor image problem for the last year or so. The pricing issue blew up when Martin Shkreli’s Turing Pharmaceuticals hiked the price of an older AIDS drug it acquired. New controversies over business moves by other companies like Mylan and Valeant have only dialed up the scrutiny on the industry.
Meanwhile, innovative drugs like Gilead’s Sovaldi (sofosbuvir) have taken on some of the backlash. While the drug has a high price — $1,000 per pill — it was a new, innovative discovery that actually cures patients with hepatitis C, saving them from needing a liver transplant.