Affordable and Safe Prescription Drug Importation Act of 2024
The proposed legislation is projected to transform the landscape of drug pricing in the U.S. by enabling access to lower-cost alternatives from abroad, thus addressing the crisis of unaffordable medications. Importation under this act would require the establishment of regulations by the Secretary of Health and Human Services within one year of enactment, defining how imported drugs will be vetted for safety and efficacy. The Secretary will also have to maintain oversight on the quality of drugs being imported and ensure that no counterfeit medications enter the market.
House Bill 8848, also known as the Affordable and Safe Prescription Drug Importation Act of 2024, seeks to amend the Federal Food, Drug, and Cosmetic Act to facilitate the importation of safe and affordable prescription drugs into the United States. The bill emphasizes the high costs of prescription drugs in the U.S., typically 2.78 times higher than in comparable OECD countries. It aims to allow individualized and wholesale importation from certified foreign sellers based in nations with rigorous pharmaceutical regulations, including Canada, the UK, EU member states, and Switzerland.
Despite its potential benefits, the bill has raised concerns among various stakeholders, particularly regarding the safety of imported drugs. Proponents argue that it introduces necessary competition in the pharmaceutical market, while opponents worry about the risks associated with drug safety and efficacy standards in foreign markets. Critics also emphasize that while lowering costs is critical, the implications for public health and the integrity of the U.S. drug approval and monitoring system need to be carefully considered to avoid any adverse health outcomes.