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What are the Implications of the 21st Century Cures Act?

What are the Implications of the 21st Century Cures Act?
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Linda Girgis, MD

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Linda Girgis, MD (click to view)

Linda Girgis, MD

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On December 13, 2016, President Obama signed the 21st Century Cures Act into law. While the overwhelming majority supported this act, many others expressed their concerns about what the implications of this bill would be.

Getting New Medications to Market

The goals of this bill are multifaceted.  One of the chief aims is to reduce the time it takes a new medication to come to market. Typically, clinical trials are conducted to determine the safety and efficacy of these drugs, and this process can take years until results are available. Under this new law, the FDA is encouraged to find alternative statistical analyses to speed up the process. Many opponents claim that this will result in unsafe therapies being pushed through for the benefit of pharmaceutical company profits. While the drug companies definitely have a new advantage, the FDA is still overseeing the process. No one is instructing them to throw science out the window, but rather develop new tools.

Having medications available at a faster rate is a true win for patients. Many terminally ill cancer patients sit waiting to die because there are no more treatments left for them. Additionally, rare disease patients now have hope that a cure may become available where no cure existed previously. The FDA is still tasked with making sure they are safe.

Funding & The Opioid Epidemic

Under this bill, funding will be provided for additional research as well. In the past, this was a huge barrier for the scientific community. While an idea may be great, it will not go anywhere without the monetary means of bringing it to life.

Additionally, the 21st Century Cures Act will give additional funding to states in the fight of the opioid epidemic. As we observed in recent news reports, this epidemic is spiraling out of control. People lives are being lost with it and, unless we take strict action, many more lives are at stake. As a physician, finding resources for patients to fight this addiction within themselves has been a nearly impossible mountain to surmount.  But now, states can set new resources into play with this additional money and save lives.

It is important to remember that it is not only the addict’s life that is destroyed with the addiction, but also the lies of those who interact with him/her, such as family and friends. This epidemic is costing uncountable amounts of money. However, the destroyed lives it leaves in its wake are truly unimaginable.

Resources for Mental Health

This bill will also address mental health issues and give a boost to resources in this area. For decades, mental health services have been paltry and stigmatized. Patients often feel ashamed to admit they may have a mental health problem and do not seek out help. Now, with new resources, it is time to erase these stigmas and get rid of the shame. Everyone needs to know that mental health diseases are the same as physical disease such as diabetes and asthma. We need to offer the same care as we do for those disorders.

While many may fear what will happen under this bill, we can only hope it is rolled out for the advantage of patients. As a healthcare system, we need to place patients back as our main objective, not profits or political agendas. This law gives hope to many who have none left. Now, shouldn’t we all make sure this new hope is realized?

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