UPDATE — 21ST CENTURY CURES ACT
Manhattan Institute’s Project FDA has been at the forefront of advocating for FDA reform since 2006. A wide array of experts has been central to Project FDA’s reform efforts, including former FDA Commissioner Dr. Andrew von Eschenbach, Nobel Prize winning molecular biologist Phillip Sharp, and former Oklahoma Senator Tom Coburn. Project FDA recognized early on that the barrier to advancing better treatments was an outdated regulatory framework, dating back to the mid-20th Century, to developing drugs.
On November 30th, the U.S. House voted to pass the 21st Century Cures Act. Manhattan Institute senior fellow and director of health policy, Paul Howard, wrote:
"The House’s vote to pass the 21st Century Cures Act is the culmination of nearly three years of bipartisan collaboration on how to best sustain and accelerate biomedical innovation in the U.S. This effort reached far beyond the Beltway and engaged everyone: patients with rare diseases, leading researchers at America’s best universities, industry experts, the FDA, and NIH."
Project FDA is a Manhattan Institute initiative that aims to reform the FDA to meet 21st century challenges. Project FDA promotes reforms that can enable the FDA to offer a more predictable, transparent, and efficient pathway for bringing safe and effective new products to patients.
Medicine is on the cusp of a radical transformation. New sciences and technologies are poised to allow physicians to personalize treatment for every cancer patient; arrest or prevent the development of Alzheimer's disease; and radically lower health care costs by reducing the prevalence of expensive chronic diseases. Unfortunately, today's FDA has struggled to adapt its regulations to new scientific advances.
"The House’s vote to pass the 21st Century Cures Act is the culmination of nearly three years of bipartisan collaboration on how to best sustain and accelerate biomedical innovation in the U.S." — Paul Howard
Project FDA believes the FDA can become a bridge for innovation, rather than a barrier to it, and that this can be achieved without sacrificing patient safety. For instance, advances in molecular medicine that allow companies to target specific sub-groups of patients, combined with electronic health records, should allow the FDA to streamline and improve time-consuming and expensive pre-market product testing that can take a decade or more, and implement vigorous post-market surveillance of "real world" patients after drugs or devices demonstrate safety and efficacy in early testing. This approach will not only accelerate access to innovative products; it should enhance efforts to safeguard public health.
Project FDA will educate the public on the FDA's vital role in advancing medical innovation; highlight the potential for new sciences to improve health while also lowering costs; and collaborate with patients' groups, industry stakeholders, and policymakers to modernize the FDA's policies and procedures.