21st Century Cures Act

There’s no doubt that the health care system could use some care of its own. Although more people are being covered under health care plans than ever before, there is still a lot of opportunity to improve not only the methods by which we diagnose and treat everyday conditions and sickness, but also how we research rare and deadly diseases, such as mesothelioma.

The good news is that recognition of this fact is starting to make its way through the legislative system. Earlier this year, on July 10, the U.S. House of Representatives approved the 21st Century Cures Act – a bipartisan bill that managed to make its way past the often contentious Energy & Commerce Committee with a resoundingly unanimous 51-0 vote.

Now, it just needs to pass the Senate.

What the 21st Century Cures Act Does

In addition to general administrative updates – such as provisioning the budget of the National Institutes of Health (NIH) over the next three years – the 21st Century Cures Act is designed to “accelerate the discovery, development, and delivery of 21st century cures.” But how exactly does it do these things?

Here’s the breakdown.

Research Enhancements

One aspect the 21st Century Cures Act is to sweep unnecessary bureaucracy out of the way. Section 1023 of the act require the Director of the NIH to create a plan that significantly reduces the administrative burdens on researchers, taking into account advice from groups like the National Academy of Sciences and the Scientific Management Review Board.

Although it might take some time to assess the current situation and get rid of unnecessary requirements, this long-term goal of easing the burdens on researchers will go a long way into developing cures for cancer and other deadly diseases.

Standardized Trial Data

The 21st Century Cures Act also makes it easier to store and access data within databases managed by the NIH. A big part of that includes developing new standards for how data from clinical trials is gathered and submitted to the NIH.

Precision Medicine

Another thing the 21st Century Cures Act does is to require the FDA to come up with a definition of the term “precision drug or biological product,” as well as to deal with certain issues related to what has become known as precision medicine.

The concept of precision medicine is to develop drugs and other treatments that rely on the individual genetic makeup of the patient. For example, recently Intel and the Knight Cancer Institute at Oregon Health & Science University (OHSU) announced a partnership called the Collaborative Cancer Cloud, which would help study the genomic features of cancers from patients around the world, and eventually help determine courses of treatment based on genetic factors.

Biomarker Framework

As part of the research and development of new drugs, researchers identify what are known as biomarkers – measurable indications that a disease, infection, toxic exposure, or other health-related condition might exist. For example, the presence of soluble mesothelin-related peptides (SMRP) in the blood has been identified as a potential way to diagnose mesothelioma earlier, thus possibly improving prognosis.

Section 2021 of the 21st Century Cures Act requires the Secretary of Health & Human Services to establish a collaborative framework for submitting, reviewing, and qualifying biomarkers and other drug development tools. It would also make information about drug submissions and development public. The idea here, as explained in a fact sheet created by the Energy & Commerce Committee, is to expand the FDA’s ability to understand benefits and risk of drug development through the use of new tools and better medical technology.

Innovation Fund

Perhaps one of the most intriguing provisions of the 21st Century Care Act is the development of a “Cures Innovation Fund” to be administered by the NIH. This fund includes $1.75 billion that will be used for biomedical research. This includes various types of research, such as early stage investigations and research done by small businesses.

The impact of the Cures Innovation Fund is potentially enormous, as it specifically allows for new investigations to be undertaken by many more people, thus increasing the chance that a cure for cancers like mesothelioma may come about.

Next Steps for the 21st Century Cures Act

The 21st Century Cures Act was passed in the House in a rare display of bipartisanship. Now, it’s up to the Senate to show the same level of cooperation and pass the bill as well, so it can be sent on to President Obama for signing into law.

Unfortunately, it doesn’t seem likely that the Senate will vote on the bill anytime soon. After the House passed its version of the bill, Sen. Lamar Alexander (R-Tenn.) – Chairman of the Health, Education, Labor and Pensions Committee, where the bill is currently lying dormant – released a statement saying that the bill likely won’t be taken up by the Senate until sometime in 2016.

In the meantime, for those who support the act, call your senators and tell them to vote “Yes!” on the 21st Century Cures Act.