21st Century Cures Act passes in House of Representatives

The House of Representatives has passed H.R. 6, the 21^st Century Cures Act, which aims to improve the drug development process by speeding up medication and device approvals, according to a press release.

“The pace of scientific advancement over the past two decades, including the mapping of the human genome, has been impressive, giving us a myriad of genetic clues about the underpinnings of disease. Translating these discoveries into new treatments for patients, however, has proven to be difficult. H.R. 6 accelerates the discovery, development and delivery of life saving and life improving therapies, and transforms the quest for faster cures,” according to a press release from the U.S. House of Representatives’ Committee on Energy and Commerce’s Chairman Fred Upton.

The bill will amend the Public Health Service Act, which re-authorizes the NIH through fiscal year 2018. The Cures Act creates the Innovation Fund, which will provide $1.75 billion annually to the NIH and $110 million annually to the FDA, for the next 5 years. This funding will be used to invest in the upcoming generation of scientists and precision medicines that could lead to new drug and device development, according to the release.

In addition to the new innovation fund, the bill sets up a council that is responsible for fast-tracking the discovery and development of new treatments and preventative measures. The Council will consist of the NIH Director, the FDA Commissioner and the CMS administrator, along with other members of federal agencies.

H.R. 6 will allow for a more streamlined process for drug development by removing barriers that slow down the process between scientific discovery and patient availability. Research data will be more easily accessible, which means more opportunities for collaboration among researchers, according to the release from Chairman Upton.

When the FDA reviews and approves new drugs and devices, they will now be able to take the direct experience of patients and use biomarkers, rather than relying on clinical trials alone.

Developing treatments for rare diseases will now come with economic incentives which would lead to more cures in less time, according to the release.

Now that the bill has passed in the House, H.R. 6 will go before the Senate for approval.

“The 21^st Century Cures Act, will bring our health care innovation infrastructure into the 21^st Century, delivering hope for patients and loved ones and providing necessary resources to researchers to continue their efforts to uncover the next generation of cures and treatments,” according to a press release from the Energy and Commerce Committee.