Last week, President Obama signed into law the largest piece of health care legislation since the Affordable Care Act. The law — known as the 21st Century Cures Act — has the potential to invigorate medical research, promote innovation and speed the development of new treatments for cancer and other chronic diseases. In addition, the law allocated funding for specific work in the areas of mental health services and opioid addiction research. The bill provides more than $6 billion in funding and is a welcome relief to scientists who depend on funding for important medical research from the National Institutes of Health. The law — the result of bipartisan cooperation — may also significantly impact the way the Food and Drug Administration operates when approving new drugs and medical devices.
How the Law Will Impact Health and Science
By funding the NIH with nearly $4 billion in research dollars, the Cures Act will allow important research to continue and will spur innovation. The NIH funds nearly 35,000 projects ever single year. NIH-generated breakthroughs have led to decreases in mortality rates for heart disease, cancer and other chronic diseases. Academic medical centers depend on NIH funding in order to continue to conduct important clinical trials that ultimately lead to new medicines, treatments and, in some cases, cures for once incurable diseases. In addition, the advances that are made possible through NIH grants have resulted in research jobs, economic growth, increased productivity and decreased disease burden, both in the United States and throughout the world. A Congressional study from 2000 found that nearly 60 percent of the most important drugs on the market today resulted from NIH-funded research grants. For example, the NIH funded the Human Genome Project, which may be one of the most important research endeavors of our time.
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How Will The Cures Act Change the FDA?
Currently, the FDA regulates all the new drugs and devices that enter the U.S. market. The FDA is loaded with red tape, and it can be incredibly expensive for pharmaceutical and medical device companies to get new products through the approval process — often costing billions of dollars from the start of the drug creation process to the end of the approval timeline. The FDA is charged with making sure that consumers are protected from unsafe medications and devices and are singularly focused on this goal. Currently, in order for a drug to meet the approval of the FDA, large amounts of data supporting the safety and efficacy of the drug or device are required. The FDA prefers that this data be the result of large randomized controlled clinical trials — the most reliable type of evidence that is available from research. RCTs are expensive to conduct and often take years to complete. Under the Cures Act, companies will be allowed to submit observational data and “in house” registry data as evidence for the safety and efficacy of a new product. This is likely to result in a substantial cost savings, but opponents worry that the new policy may result in unsafe products making it to the market and putting patients at risk. Proponents of the law argue that the current high costs related to FDA approval discourage innovation and keep smaller companies and entrepreneurial enterprises from entering the process. Many believe that the Cures Act will promote the development of new ideas that can have a more immediate impact on health and medicine.
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Mental Health, Addiction and More
The Cures Act also addresses the opioid crisis. More Americans died from overdoses in 2016 than from motor vehicle accidents. The new law provides important funding for the treatment and prevention of opioid addiction. In addition, the law creates a new government position: Assistant Secretary for Mental Health and Substance Abuse. Access to mental health treatment services in the United States must be improved, and the Cures Act will provide a substantial focus on improving care for those who need it.
What’s Missing?
While the 21st Century Cures Act goes a long way toward making medical innovation work for every American, there’s more that needs to be done. Most critics of the law suggest it allows for drug and device makers to go unchecked. Many pharmaceutical companies continue to price-gouge and charge exorbitant prices for common drugs. Another common criticism is that certain companies and CEOs represent all that is bad in the medical drug and device industry — they line their pockets with money at the expense of patients who need both treatment and hope. Recently, a federal lawsuit was filed against several generic drug makers due to accusations of colluding to “fix” prices — all at the expense of the medical consumer. We can no longer allow the pharmaceutical and medical device industry to go unchecked. The new law will certainly spur innovation and hopefully decrease costs — but we must also look to Congress to examine the pricing practices of pharmaceutical and device companies. The United States can no longer bear the research and development costs for the rest of the world.
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Looking Forward….
Ultimately, I believe that the 21st Century Cures Act will play an important role in the development of new treatments and cures for chronic diseases over the next decade. We have some of the best and brightest medical minds in the world here in the U.S., and it’s vital that we continue to fund their important work. By using research in genomics and personalized medicine, it is likely that we will, in fact, find a cure for certain cancers as part of the “Cancer Moonshot” over the next decade.
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The 21st Century Cures Act: Saving Lives Through Research originally appeared on usnews.com