Research and development continues long after a medicine is initially approved

The government’s flawed price setting plan under the Build Back Better Act will significantly upend the biopharmaceutical research and development (R&D) process, risking important advances in patient care that are only discovered through continued research on already approved medicines. The plan gives the government a new authority to set prices for selected medicines in Medicare after a medicine has been approved for a certain number of years, unless there is a generic or biosimilar version of the medicine available on the market at the time of selection. The plan guts existing incentives necessary to support further investment in post-approval R&D, creating uncertainty for advances that help meet unmet patient needs and stopping progress in its tracks.