The 21st Century Cures Act finally passed this week with overwhelming bipartisan support. In May 2015, the proposed legislation (H.R. 34) was introduced in the U.S. House of Representatives, with the goal of promoting the development and speeding the approval of new drugs and devices. Experts at the New England Journal of Medicine believe its provisions could have a profound effect on what is known about the safety and efficacy of medical products, as well as which ones become available for use.
President Barack Obama has indicated that he would sign the bill into law as soon as it reached his desk, enacting $4.8 billion of new funding for the National Institutes of Health (NIH) and $500 million for the Food and Drug Administration (FDA), as well as many policy provisions that will strengthen the entire biomedical innovation system. President Obama made the following remarks about the Cures Act in his radio address on Dec. 2:
“First, it will make real investments this year to combat the heroin and prescription drug epidemic that’s plaguing so many of our communities. Drug overdoses now take more lives every year than traffic accidents, and deaths from opioid overdoses have nearly quadrupled since 1999.
The second thing the Cures Act does is make a significant investment in Joe Biden’s Cancer Moonshot. I set a goal of making America the country that ends cancer once and for all – and I put the Vice President in charge of Mission Control. This bill will allow us to invest in promising new therapies, in new ways to detect and prevent cancer, and to develop more vaccines for cancer just as we have them for measles or mumps.
Third, we’ll be giving researchers the resources they need to help identify ways to treat, cure, and prevent all kinds of brain disorders. Alzheimer’s. Epilepsy. Traumatic Brain Injury. And it also supports the Precision Medicine Initiative, an effort we started to bring doctors and data together to develop treatments and health care that one day can be tailored specifically to you. That can lead to some big breakthroughs.
Fourth, the Cures Act includes bipartisan mental health reforms, including important programs for suicide prevention. And fifth, we’re making sure the FDA incorporates patients’ voices – your voices – into the decisions they make as they develop drugs.”
AAMDSIF will work to ensure that your voices are heard, so stay tuned. We’ll provide updates on the implementation of the portions of the Cures Act that will impact you.