Regulatory review is often seen as a barrier to innovation, increasing costs and delaying new medicines. Yet approval may also expand markets by certifying quality and reducing uncertainty. We test this by studying FDA approval for follow-on indications—uses that physicians could already prescribe “offlabel” — and find approval raises use in newly approved diseases by 25 percent within a year, with larger increases in smaller off-label markets. Subsequent approvals in the same disease yield smaller gains. Our results suggest regulatory approval of medicines expands market size by increasing demand, rather than easing insurer-imposed restrictions, revealing limits to marketbased learning.

We develop a framework to measure the role of hospital allocation in racial disparities in health care and use it to study Black and white heart attack patients. Black patients receive care at lower-performing hospitals than white patients. However, over two decades, the performance gap between hospitals treating Black and white patients shrank by over two-thirds. This progress is due to more rapid performance improvement at hospitals that tended to treat Black patients rather than reallocation of patients. Hospital improvement is correlated with adoption of a productivity-raising input, beta blockers. Our work highlights reallocation and performance improvement as future disparity-reduction levers.

Regulators of new products confront a trade-off between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to innovate around this trade-off. We find that the BTD program shortened clinical development times by 23% and did not affect the ex post safety profile of drugs with the designation. The BTD program had the greatest impact on less experienced firms and reduced clinical trial design complexity. The results suggest that targeted regulatory innovation can shorten R&D periods without compromising product quality.