The 21st Century Cures Act is a new law signed by President Obama aimed at empowering medical research, simplifying drug approvals, and allocating funds for mental health services and opioid addiction studies.
The Powerful 21st Century Cures Act
A powerful law in the field of health care, it promises to allocate around $6 billion for funding in the field of medical research and the fight against cancer, mental health issues and the opioid wave.
The 21st Century Cures Act designated $4.8 billion for the National Institutes of Health, of which, $1.8 billion is kept for the "cancer moonshot" project. Additional $1.6 billion is allocated for brain diseases, which include Alzheimer's disease. Also included are $500 million funding for the Food and Drug Administration and $1 billion in grants to help states deal with opioid issues.
President Obama commended the act and extended his support.
"We are now one step closer to ending cancer as we know it, unlocking cures for diseases like Alzheimer's, and helping people seeking treatment for opioid addiction finally get the help they need," said Obama in a statement. He further added that the act will make a big difference when both the parties will work in unison for betterment of people's health and lives.
How The Act Can Impact Peoples' Lives?
The act can largely influence the lives and health of people. In addition to medical research, it is extensively dedicated to mental health services, the opioid epidemic, and cancer research through the Moonshot project.
It also promises on reinforcing mental health parity laws and improving access to mental health treatment services in the United States. The act aims at providing sufficient fund allocation for the treatment and prevention of opioid addiction. In addition, the act assures speeding up of cancer research programme through Vice President Joe Biden's moonshot project.
How The Act Will Modify The FDA?
To date, all new drugs and piece of medical equipment that enter the United States market are governed by the FDA. The formalities for getting approval from FDA are complicated and can be really expensive for the drug and medical device companies. They also have to submit large number of documents to the FDA stating the efficiency and safety of the drug or device pending an approval. FDA expects this documentation to be the result of numerous Randomized Controlled Trials or RCTs. Since RCTs are highly pricey and take years to complete, the approvals can prove to be very costly and time-consuming.
As per the 21st Century Cures Act, medical companies will just need to give in the observational data and "in house" registry information to the FDA, as proof to show the efficiency and safety of their new medicine or equipment. This change may lead to significant time and cost-cutting in the process of obtaining approvals.
