Bioethics Blogs

Modernizing Biomedical Innovation: Understanding the 21st Century Cures Act

by Avery Avrakotos, education and policy consultant

On July 10, 2015, the US House of Representatives passed H.R. 6, the 21st Century Cures Act, with a vote of 344-77. The passage of the bill, which many have hailed as a noteworthy example of bipartisan collaboration, is the result of more than a year of congressional hearings, roundtable discussions, whitepapers, and political debate. First introduced in April 2014 by Fred Upton (R-MI), chairman of the US House of Representatives’ Energy and Commerce Committee, and Representative Diana DeGette (D-CO), the 21st Century Cures initiative seeks to “accelerate the pace of cures in America.”

The legislative phase of the 21st Century Cures initiative began in January 2015, with the release of the first discussion draft of the bill. This version proposed major changes to the drug and device development process and touched on issues related to human subjects protections, the sharing of clinical trial data, expanded access, adaptive clinical trial designs, orphan drugs, and much more. The reaction to the discussion draft was varied, with supporters hailing the collaborative and transparent nature of the bill’s development, and critics voicing concerns over provisions that they believed would negatively affect patient safety.

Over the next several months, additional discussion drafts were released and the 21st Century Cures Act was further refined, with later versions representing “a less aggressive streamlining of the drug approval process.” Nonetheless, the version of the 21st Century Cures Act that was passed by the House on July 10 proposes significant changes and has prompted debate among scientists, academics, industry representatives, patient advocacy groups, and regulators.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.