By Deena Beasley
June 25 (Reuters) - Launch prices for prescription medicines approved by U.S. regulators in 2025 fell from the previous year, but remained high at a median of $216,000 due to expensive drugs for rare diseases, a new analysis shows.
In 2024, the median annual list price of a new drug was over $370,000, up from $300,000 in 2023 and $222,000 in 2022.
Drug pricing experts attributed the dip to the mix of types of drugs approved rather than a significant shift in pricing strategy or government
policies aimed at lowering prescription drug prices. The Food and Drug Administration last year approved five cell and gene therapies versus seven in both 2024 and 2023. Gene therapies, which are given once, can have prices in the millions of dollars.
Many new medicines target serious, complex diseases with few or no treatment options, and it is "misleading" to compare those prices to other drug types, trade group Pharmaceutical Research and Manufacturers of America said in an email.
More than 67% of FDA approvals in 2025 were for small- molecule drugs, such as pills, which are made from chemicals, rather than costly, complex biologics derived from living cells. That number was up from 2024, when small molecules accounted for 62% of approvals, and 2023, when it was 57%.
New biologics are often first-in-class and do not have competitors, allowing drugmakers to charge high prices, said Richard Frank, director at the Brookings Institution's Center on Health Policy.
The average launch price for a drug approved in 2025 was $416,000, as lower-cost products like $1,050 for LENZ Therapeutics' Vizz eye drops for blurry vision and $5,400 cholesterol drug Lerochol from LIB Therapeutics offset expensive treatments for rare genetic disorders like Mighty Therapeutics' Forzinity for Barth syndrome, priced at nearly $800,000 a year.
POLITICS PLAYS A ROLE
"It is hard to make a lot of assessments about trends based on a single year," said Dr. Benjamin Rome, an assistant professor at Harvard Medical School who researches drug prices, adding that "2025 was an odd year."
He said the FDA was buffeted by Trump administration reorganization efforts, including staff cuts and leadership changes. The agency rejected several gene therapies, leading to a backlash from patient advocates and political controversy. Earlier this year, the FDA said it would take a more flexible approach.
Drugmakers came under pressure from President Donald Trump, who has sought to claim victory in tackling high U.S. pharmaceutical prices with the TrumpRx platform for direct-to-consumer sales, and deals with large companies to bring U.S. prices in line with those in other developed nations.
Those agreements are unlikely to last beyond the current administration, said Brookings' Frank.
Rome also said that without legislation, the agreements will not significantly impact pricing decisions.
"There's been this broad trend to say look what I'm doing to lower drug prices," but a lot of it is "performative," said Geoffrey Joyce, director at the University of Southern California's Schaeffer Center for Health Policy & Economics.
NEW DRUGS FOR CANCER, RARE DISEASES
The FDA approved 51 new drugs last year, 46 at its main division and the five cell and gene therapies. The agency approved 57 new drugs in 2024 and 55 in 2023. Those tallies do not include imaging agents, blood testing reagents or vaccines.
The analysis of 42 drug prices compiled by 3 Axis Advisors also excluded drugs used intermittently like antibiotics and products that have not yet launched commercially.
Cancer drugs remained the most represented therapeutic area, accounting for about a third of 2025 FDA approvals.
As in recent years, more than half of the approvals were "orphan" drugs, meaning they treat conditions affecting fewer than 200,000 Americans. Drugmakers are given incentives to invest in research for rare diseases, including longer market exclusivity, and often charge premium prices for the niche products.
While calling that "wise public policy," USC's Joyce noted that drugmakers have "gamed" those incentives.
They can develop a drug that's effective for a wide range of conditions but seek approval for "a low-prevalence disease... and get all the benefits and all the tax write-offs," he said. "The logic is to launch (at a price) as high as you think you can get away with."
Drug companies emphasize that new medicines can offer cost-saving value, including potentially fewer emergency room visits and hospital stays.
The analysis looked only at list prices and did not include the undisclosed discounts and rebates that insurers can receive from manufacturers.
"You're still paying hundreds of thousands of dollars for most new drugs... irrespective of whether they offer a huge benefit over existing drugs or are sort of novel products that don't offer much benefit," Harvard's Rome said.
(Reporting By Deena Beasley; Editing by Caroline Humer and Bill Berkrot)
