Leo’s Law

Key Points

• This bill, known as Leo’s Law, adds 180 days to the time a drug company has exclusive rights to sell a new medicine for a rare disease. During this extra six months, other companies are blocked from selling cheaper generic versions of the drug.
• It specifically helps "orphan drugs," which are treatments for diseases that affect a small number of people. To qualify for the extension, the company must have applied to test the drug during the COVID-19 emergency period.
• The change is meant to help companies that lost time or money because the pandemic disrupted their research and clinical trials. By giving them more exclusive time, the government aims to keep companies focused on finding cures for rare conditions.
• For patients and insurance companies, this could mean that the price of these specific rare disease drugs stays high for a little longer, as generic competitors will be delayed from entering the market by about half a year.

Impact Analysis

Govbase has not yet run an impact analysis on this legislation.