21st Century Cures Act

21st Century Cures Act is a United States legislation, signed into law on December 13, 2016, with the aim of accelerating the research, development, and delivery of medical treatments and cures. The Act provides funding for various aspects of the healthcare industry, including biomedical research, medical device innovation, mental health research, and efforts to combat the opioid epidemic.

Overview

The 21st Century Cures Act was passed with bipartisan support and is considered a significant piece of health-related legislation. It authorizes $6.3 billion in funding, primarily for the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). The Act also includes provisions aimed at improving mental health services and increasing the rights of patients in their healthcare decisions.

Provisions

The Act is divided into several titles, each addressing different aspects of healthcare and medical research.

Title I: Innovation Projects and State Responses to Opioid Abuse

This title provides $1 billion in grants for states to supplement their efforts in combating the opioid epidemic. It also establishes the NIH Innovation Fund, which is allocated $4.8 billion over 10 years to accelerate the discovery, development, and delivery of new treatments and cures.

Title II: FDA

This title includes provisions to expedite the FDA's drug and device approval processes. It also establishes a program for the breakthrough designation of medical devices, similar to the existing program for drugs.

Title III: Delivery

This title includes provisions aimed at improving the delivery of healthcare, including the use of health information technology and efforts to increase patient access to their own health information.

Criticisms

While the Act has been praised for its potential to accelerate the development of new treatments and cures, it has also faced criticism. Some critics argue that the Act could lower standards for drug and device approval, potentially putting patients at risk. Others express concern that the Act does not do enough to address the high cost of prescription drugs.

See also

• National Institutes of Health
• Food and Drug Administration
• Opioid epidemic
• Healthcare in the United States