ICYMI: The current golden age of medical discovery is threatened by “short-sighted U.S. government policy,” BIO CEO Rachel King warns in MarketWatch.
The good news: More novel therapeutics were approved in 2023 than almost any year in the 21st century, including:
The bad news: Inflation Reduction Act (IRA) price controls could force companies to halt research—particularly small companies, which originate 64% of approved drugs.
Patients will suffer: Orphan drugs for rare diseases are exempt from price controls, but the exemption will be lost if approved for a second indication—a common way of discovering new treatments.
The ORPHAN Cures Act would help by maintaining exemptions for orphan drugs approved for more than one indication—something voters support.
The law also disincentivizes the most common type of drugs:small-molecule drugs, which have a nine-year exemption; biologics have a 13-year exemption. “Different timelines for small-molecule and biologic drugs makes little sense, given that we need both types of medicines,” says King.
The bottom line: “If leaders are serious about helping patients, policymakers on both sides of the aisle should work together to offset the most harmful parts of the IRA,” she says. “We’re at a moment of great medical progress. But we also need wise policy to ensure that it bears fruit.”
The context: “By Feb. 1, the federal government will send an initial offer for each of the 10 drugs selected for the first round of negotiations under the program,” reports MarketWatch.
Read and share Rachel King’s op-ed.