Objective: To examine how drug manufacturers disclosed prices for new molecular entities approved by the FDA between 2022 and 2024.
Study Design: Retrospective study.
Methods: We included drugs approved through new drug applications or biologics license applications, excluding imaging agents, vaccines, blood products, and drugs without an assigned National Drug Code. For each drug, we assessed whether pricing was disclosed proactively (ie, in news releases or earnings calls) or reactively (ie, in media reports citing the company without prior proactive disclosure). We sourced launch prices from public disclosures and California filings. We also recorded company market capitalization, orphan drug designation, accelerated approval status, and Institute for Clinical and Economic Review assessments.
Results: Of 150 drugs, 107 (71%) had publicly disclosed launch prices: 49 proactively and 58 reactively. Proactive disclosure was more common among public companies with smaller market capitalizations—69% for firms worth $1 billion to $10 billion, compared with 7% for those worth more than $100 billion.
Conclusions: We found that pharmaceutical companies proactively released launch prices for one-third of drugs approved from 2022 to 2024 and reactively released prices for an additional 39%. Our findings suggest that securities regulations may influence disclosure behavior, particularly for smaller public companies. Greater transparency at launch could support better-informed public discourse on drug pricing and value.