21st Century Cures Passes Congress and is Signed into Law

Baker Donelson
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Baker Donelson

After more than four years of halting progress, Congress approved and the President signed the 21st Century Cures Act. The legislation, which passed the Senate 94 to 5 and the House 392-26, authorizes $6.3 billion in spending, addressing weaknesses in the nation's mental health systems and altering the regulatory system for drugs and medical devices.

A rare bipartisan, bicameral effort, the act authorized spending on a number of priorities, including $4.8 billion in biomedical research initiatives and $500 million to help states prevent opioid misuse and provide additional treatment options. The act also authorizes funding to support President Obama's Precision Medicine Initiative, the BRAIN initiative, and Vice President Biden's Cancer Moonshot.

Finally, the 21st Century Cures Act also provides additional authorities to government agencies to partner with private sector companies to develop new drug therapies and medical devices and to expedite federal approval for newly developed treatments. The act expands the National Institute of Health's authority to finance high-risk, high-reward research with special procurement procedures, allows for the creation of "eureka prize" competitions, and speeds up review of drugs and devices at the Food and Drug Administration.

The act also takes steps to improve mental health care by creating a new Assistant Secretary for Mental Health and Substance Abuse and directs federal agencies to step up enforcement of laws on mental health parity.

The act was not uniformly supported, facing opposition from both the Democrats wanting to address drug pricing and how drugs are brought to the market and Republicans who objected to mandatory spending levels. In order to pay for the additional spending the bill cuts roughly $3.5 billion – about 30 percent – from the Prevention and Public Health Fund.

Takeaway: The 21st Century Cures Act is one of the biggest pieces of legislation focusing on health care to pass since the Affordable Care Act and one of the final pieces of legislation signed into law by President Obama. The fact that it was bipartisan and bicameral and passed with overwhelming majorities is testament to the four years of work that was put into ensuring there was something for (nearly) everyone. The legislation's expected impact on biomedical research, cancer treatment and prevention, drug discovery and approval, and mental health care will touch nearly all Americans.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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