The 21st century cures act: Opportunities and challenges.

Abstract

On July 10, 2015, the U.S. House of Representatives overwhelmingly voted (344-77) to approve the 21st Century Cures Act, setting the stage for the Senate to consider its own version of the bill this fall. Such strong bipartisan support, rare in an age of congressional gridlock, might logically be interpreted as a sign of the Act's promise to foster innovative drug and device development. However, careful inspection reveals that while the Act contains some positive features, it represents a poor deal for Americans on balance that could result in the entry of more dangerous and ineffective drugs and devices onto the market and erode trust in the US Food and Drug Administration (FDA).