Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.
The 21st Century Cures Act aims at strengthening funding for the National Institutes of Health (NIH) by allocating over $ six billion to them. Of this, nearly $ five billion will go towards biomedical research funding. One of the highlights of the 21st Century Cures Act is the allocation of nearly $ two billion for the “Beau Biden Cancer Moonshot” initiative, which is in honor of the Vice President Joe Biden’s son, who succumbed to brain tumor.
A different take on health improvement
This approach is a significant one, considering that researchers from some of the nation’s best-known science universities depend on NIH funding for their research. Nearly two thirds of the major drugs that are in the market since 2000 have been the result of NIH research.
In addition, the 21st Century Cures Act will also have a major impact on mental health. This is one of the most notable features of this Act. It allocates over a billion dollars for addressing opioid and other addictions in the US, and the health-related complications that arise from them, which is a significant contributor to the fall in national health standards and productivity of the population in its prime.
Will the 21st Century Cures Act change the FDA approval process?
While addressing this core aspect of scientific research in helping to treat chronic diseases; the 21st Century Cures Act also focuses on another very critical point of medicines: The FDA. Since no drug can ever enter the market without FDA approval and the FDA approval process is very lengthy, expensive and cumbersome; the 21st Century Cures Act seeks to address this fundamental issue by suggesting changes into the approval process for new drugs, as well as medical devices.
Concerns and criticisms
Reservations have been expressed about the effectiveness of the 21st Century Cures Act. The main concern is that the regulatory approval process of drugs from the FDA could get diluted, causing a risk to the lives of the patients, thereby reducing the ability of the FDA to protect lives with its regulations.
There are many issues at stake in this highly important legislation. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will discuss the prospects and downsides of this very important law.
At this webinar, John E. Lincoln, a very experienced medical device and regulatory affairs consultant, will offer a complete insight into the provisions of the 21st Century Cures Act. This webinar will be highly meaningful and useful for research institutions and organizations that are directly concerned and connected with the FDA and its administration of emerging technologies and general health. Enroll for this webinar by registering at http://www.compliance4all.com/control/w_product/~product_id=501213?Worpress-SEO
Analysis of all the major aspects of the 21st Century Cures Act
John will explain and analyze all the main areas of the 21st Century Cures Act. He will scrutinize how the Act will concern the FDA, the impact it will have on other areas of the Federal government, and the possible benefits and drawbacks for industries and research institutions that will get directly and indirectly affected by the Act, and the general public.
John will cover the following areas at this webinar:
- The Act’s 3 Main Areas
- Increased Funding for Medical Research
- Speed the Development and Approval of Experimental Treatments
- Overhaul Federal Policy on Mental Health Care
- Stated Advantages
- Concerns Expressed
- What Has Happened So Far