The 21st century cures act: Opportunities and challenges

Area of Science:

• Health policy and regulation
• Pharmaceutical and medical device oversight

Background:

• The U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act on July 10, 2015.
• The Act garnered significant bipartisan support, indicating potential for fostering innovation in drug and device development.

Purpose of the Study:

• To critically evaluate the 21st Century Cures Act beyond its apparent promise.
• To assess the potential impact of the Act on drug and device safety and efficacy.
• To examine the implications for public trust in the US Food and Drug Administration (FDA).

Main Methods:

• Analysis of the legislative text and its provisions.
• Assessment of potential regulatory consequences for drug and device approval pathways.
• Review of expert opinions and potential public health implications.

Main Results:

• The Act, while containing some beneficial elements, presents significant drawbacks.
• Potential for increased market entry of less safe and ineffective drugs and medical devices.
• Risk of eroding public confidence in the regulatory oversight provided by the FDA.

Conclusions:

• The 21st Century Cures Act may not be a favorable outcome for Americans.
• Concerns exist regarding the balance between innovation and patient safety under the new legislation.
• The Act could negatively impact the FDA's credibility and public trust.