Health Affairs January 9, 2023
This past year featured many significant developments in the prescription drug policy area, most notably the passage of significant prescription drug pricing reform legislation and a range of developments involving the Food and Drug Administration’s (FDA) accelerated approval program. In this post, I review five key developments from the past year and offer five items to watch for in 2023.
Looking Back: 2022
The Inflation Reduction Act
In August, Congress passed (and President Biden signed into law) the Inflation Reduction Act (IRA) of 2022, which includes three substantial reforms to Medicare’s existing system of drug pricing reimbursement (summarized in more detail here). Most notably, the IRA provides the Centers for Medicare and Medicaid Services with the authority to negotiate the...