2016 Closes with 21st Century Cures Act
A couple weeks ago Congress approved a new healthcare-centered bill called the 21st Century Cures Act. The bipartisan bill passed the House of Representatives and the Senate by large majorities and was signed by President Obama on December 13. The law allots $6.3 billion dollars towards achieving several much-needed healthcare initiatives. These include strengthening mental health care, speeding up the drug approval process to make innovative treatments more accessible, funding cancer research and brain science research, as well as combating opioid and prescription drug abuse. The bill has its own pros and cons, like any piece of legislation, but has finally come to fruition after years in the making.
The bill is expected to have an impact on the lives of those touched by all kinds of illnesses (including chronic and mental), pregnant women, children who are bullied, hospitals, and biomedical researchers, as well as people who are struggling with addiction or have a loved one who is. This population represents nearly the entirety of Americans and is indicative of the law's potential wide-spread reach.
What is covered
Of the act’s funds, $4.8 billion will be designated for use by the National Institute of Health (NIH), to support the Cancer Moonshot project (named after Vice President Joe Biden’s son, Beau, who recently passed away of brain cancer), the BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies), regenerative medicine, and the Precision Medicine Initiative, which aims to collect genetic data on a million American volunteers in order to better understand different illnesses, and more efficiently tailor treatments.
The mental health provisions include funding to suicide prevention programs, mental health services for children, the reinforcement of current laws that require mental illness to be treated the same as all others when it comes to insurance benefits, and will add a new position in the US Department of Health and Human Services who will coordinate mental health programs and initiatives across the country and governmental systems. An additional $1 billion will be allocated to the treatment and prevention of opioid use, including training clinicians to recognize warning signs, and better monitoring drug prescriptions.
Drug approval process
One of the most impactful aspects of the bill for our communities is the speeding up of development and approval for new medical devices and treatments by the FDA. The FDA will be able to use real-world, or “patient-experience” evidence when it comes to approving already established medications for the treatment of new or more conditions. There will also be new measures for establishing the efficacy of many treatments, that will be quicker, and bypass many long-term benchmarks of traditional clinical trials in favor of bringing a promising medication to research completion sooner. Many of these tactics are already used in other parts of the world, including in Europe and Asia. Opponents of the bill worry that this could lower the regulatory bar and lead to less safe and less efficient medications on the market, however, much of the focus is on expanding treatment with existing medications which could particularly benefit individuals with chronic illnesses who aren’t satisfied with their current options, and the slow-moving process to develop new ones.
While no piece of legislation is perfect, and it will need to be continually followed-up on, it could potentially provide steps in the right direction for many sectors of the healthcare field. Many organizations have joined the bandwagon in supporting the bill, including the American Psychiatric Association, American Society of Clinical Oncology, American Gastroenterological Association, American Heart Association, Arthritis Foundation, and the Association of American Medical Colleges. Let us know if you have heard about this new act, and what you think of its potential effects!
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