The median launch price of oncology drugs increased by over 8,000% between 2008 and 2021, according to a new report compiled by the office of Rep. Katie Porter (D-Calif.), from $2,115 to $180,087. The report, which draws mainly on data from the FDA’s Center for Drug Evaluation and Research (CDER), calls for reforms to the FDA approval process and Medicare’s market access rules in order to curb or unwind launch price growth, which have made oncology drugs unaffordable for many critically ill patients.
The report calls for reforms to launch price regulations, some of which could be implemented under existing FDA authority. It also examines how launch pricing dynamics may change as the federal government prepares to implement Medicare drug price negotiation — part of this year’s blockbuster Inflation Reduction Act — which will begin in 2026. The report observes that “some health policy experts project that recently enacted reforms could even apply upward pressure on launch prices,” as pharmaceutical manufacturers seek to recoup revenue that Medicare price negotiation may tamp down.