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The 21st century cures act: Opportunities and challenges
Author(s) -
Sarpatwari A,
Kesselheim AS
Publication year - 2015
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.208
Subject(s) - gridlock , food and drug administration , balance (ability) , administration (probate law) , political science , law , house of representatives , public administration , sign (mathematics) , law and economics , medicine , business , economics , legislature , pharmacology , politics , mathematical analysis , mathematics , physical medicine and rehabilitation
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).