WASHINGTON — President Donald Trump hosted representatives for Regeneron in the Oval Office Thursday to announce a new agreement with the biotechnology company to offer drugs to Americans at a lower price and mark the approval of its gene therapy treatment for genetic hearing loss.
The event was just hours after Regeneron announced that the U.S. Food and Drug Administration had granted its genetic medicine Otarmeni expedited approval under the federal agency’s Commissioner’s National Priority Voucher program. In the announcement, Regeneron said it would offer the therapy for the rare inherited hearing loss condition for free.
The condition is very uncommon, impacting about 50 newborns in the U.S. per year, according to Regeneron. But Trump in the Oval Office Thursday touted the genetic medicine as a “miracle cure” and noted that treatments for rare diseases can often cost “millions of dollars.”
He was joined at the event by a two-year-old boy who Trump said was born “100% deaf” before undergoing Regeneron’s therapy. The boy’s mother called the treatment “life-changing.”
“He is so full of energy and love now,” she said at the White House event. “He was such a serious baby.”
Regeneron noted that the fast-track FDA approval was based on “pivotal results” of a trial showing its effectiveness, including 42% of participants achieving normal hearing that included whispers.
But the Commissioner’s National Priority Voucher program it received accelerated approval under has faced questions from some Democrats in Congress recently. Some have sought more transparency around the program and noted it was not approved by Congress.
On the lower drug cost front, Trump announced Regeneron would offer its medicines moving forward to Medicaid at a price that aligns with his most-favored-nation standard. Under the policy he laid out in an executive order in May, drugs are supposed to be sold in the U.S. at the same cost as the developed nation that pays the lowest price for the same medication.
Regeneron will also offer its cholesterol drug, Praluent, at a lower price to all Americans via the website previously announced by the president as part of his drug cost cutting initiative called TrumpRx.gov. The president said the cost of Praluent will drop from $537 to $225 for patients purchasing on the website overseen by the federal government.
The agreement makes Regeneron just the latest company to announce a deal with the White House to comply with Trump’s “most favored nation” drug pricing initiative after the president sent letters to executives at major pharmaceutical firms last summer pushing the policy.
Trump Thursday said Regeneron’s deal marked the 17th company – which he said represents more than 80% of the branded drug market – to strike an agreement on the matter with the administration.
The president has held a series of Oval Office events to mark the deals in front of reporters and cameras. And this one comes as the cost of living has been shown in polls to be a major issue on voters’ minds just over six months away from the midterm elections. Democrats made the cost of health care in the U.S. in particular their central demand in last fall’s government shutdown.
Trump Thursday asserted that his “most favored nations” push has resulted in the “biggest” price reduction in drugs in the country and that Republicans should be able to “win the midterms” as a result.
“But it doesn’t work that way, unfortunately,” Trump continued. “People forget too quickly.”