President Barack Obama signed the 21st Century Cures Act on Tuesday, enacting legislation that includes funding to combat the opioid epidemic, support medical research for cancer, and speed up the approval of medical devices and pharmaceuticals.
It includes the establishment at the U.S. National Institutes of Health (NIH) of an NIH Innovation Account, which will provide $4.8 billion in support of medical research programs. Of that, $1.8 billion will be allocated over seven years to the Beau Biden Cancer Moonshot, an effort to accelerate the treatment of cancer.
The legislation received bipartisan support in Congress as well as from President Obama, but it was opposed by consumer groups and some liberal Democrats who view it as a gift to the pharmaceutical industry. The bill includes provisions that would allow a more streamlined regulatory pathway through the U.S. Food and Drug Administration (FDA) for some "breakthrough" medical technologies.
In a statement, FDA Commissioner Dr. Robert Califf said the act builds on the FDA's efforts to advance medical product innovation and ensure that patients get access to treatments as quickly as possible, while having continued assurance from high-quality evidence that they are safe and effective. The act will also greatly improve the FDA's ability to hire and retain scientific experts, he said.
"One of our ongoing challenges has been recruiting and retaining the experts we need in specialized areas to allow us to get our work done and meet our growing responsibilities," he said. "This is an especially important need given the tremendous advances in biological sciences, engineering, information technology, and data science. Preventive, diagnostic, and therapeutic strategies will become more complex with much greater potential for benefit and in some cases greater risk if used without adequate evidence to exclude risks that exceed potential benefits."
The American Association for Cancer Research (AACR) issued a statement commending President Obama and Vice President Joe Biden for their dedication to the fight against cancer throughout 2016.
"Today is a momentous occasion for the entire cancer research community and, more importantly, for the millions of people whose lives are touched by cancer," said AACR CEO Dr. Margaret Foti, PhD. "The 21st Century Cures Act is a vitally important piece of legislation that will allow us to realize Vice President Biden's goal of achieving a decade's worth of lifesaving progress against cancer in five years."
