AstraZeneca files challenge to aspects of Inflation Reduction Act

The company said, “To help protect access to medicines for cancer and rare disease patients, AstraZeneca today has filed a legal challenge to critical aspects of the drug price negotiation provisions of the Inflation Reduction Act (IRA). The drug price negotiation provisions of the IRA run headlong into the goals of the Orphan Drug Act (ODA), a federal statute designed to encourage manufacturers to invest in new therapies for rare diseases. Over the last forty years, American patients have benefited from the highly effective incentives the ODA put in place, which spurred companies to focus research and development investment on small populations of patients with significant unmet need. The passage of the ODA accelerated innovation leading to more than 600 medicines treating 1,000 rare conditions today, including cancers. Yet, the vast majority of the 7,000 known rare conditions still have no approved treatments, and continued innovation for small indications is at risk under the IRA.” Dave Fredrickson, Executive VP, Oncology Business Unit, AstraZeneca, said: “Rare disease and cancer patients depend upon high-risk, low-probability drug development that takes many years to develop and aims for cure. If today’s version of the law stands, patients in the United States with rare conditions, who have benefited from the Orphan Drug Act, will get delayed access to scientific breakthroughs relative to other parts of the world.”