Sunday, October 4, 2015

The 21st Century Cures Act: Is it an overall positive?

The below article is published in the Fall 2015 issue of the National Institutes of Health -NIDDK newsletter "The Informer"

In a rare showing of bipartisan collaboration, on July 10th the U.S. House of Representatives passed the 21st Century Cures Act by the substantial margin of 344-77. The 21st Century Cures Act is a large bill that is subtitled as “an act to accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.” According to the U.S. House of Representatives Energy and Commerce committee where the bill was drafted, the goal of the Cures Act is to streamline the process from drug discovery to development and ultimately delivery to patients. The Act promotes scientific research on deadly diseases and attempts to reduce regulatory hurdles in bringing new drugs to market.

In an era of ever-decreasing federal research funding, the bill offers a welcome boost to the research community, allocating $8.75 billion in research funds to the NIH over 5 years and an additional $550 million to the FDA. Not all scientists are in favor of the bill, however. The Cures Act aims to expedite the regulatory approval process for drugs by the FDA. As a means to this end, the bill promotes drug approval based on less rigorous clinical trials, biomarker readouts as opposed to clinical end points, and even non-quantitative anecdotal evidence in some cases. It also further reduces the rigor and objectiveness of medical device approval, which is already more lenient than the drug approval process. In the name of accelerating innovation, the bill attempts to streamline existing bureaucratic barriers to drug development and public release. However, while the bill does contain a section dedicated to “reducing administrative burdens of researchers”, it also adds additional unnecessary bureaucracy by requiring individual review by NIH institute directors of all awarded R-series grants and creating several instances of redundancy with programs or directives already in place at the NIH.  

While there are some potentially troubling issues with this bill, it is refreshing to see Congress finally recognizing the need for additional biomedical research funding. The Senate is now debating the bill and drafting their own version, but the upcoming budget debate may define whether the Cures Act is even passed this year. Assuming the 21st Century Cures Act becomes law, it will be several years before its full effects will be known. In the meantime, it is important to continue evaluating the potential long-term outcomes of this bill for everyone affected.