By Jonathan H Chen, managing partner, Medullan
On December 13, 2016, President Barack Obama signed into law the 21st Century Cures Act, which passed both houses of Congress in a rare showcase of bipartisan unity. With such broad support, it would seem that the law must be a win-win for all. But is it? As we delve deeper into what the law means for healthcare in 2017 and beyond, more information is coming to light about the real winners and losers affected by the Act. And there’s one group that stands to both win and lose the most: patients.
For many patients with life threatening illnesses, or for those whose disease is progressing, medical treatment is often the only solution left to them. These patients often do not have much time left or their disease has a debilitating impact, so they cannot afford to wait for a lengthy FDA approval process. The shortened approval process of the 21st Century Cures Act makes sense; they’ve tried other avenues, and while the treatment may have its own risks, it’s worth trying because the alternative (doing nothing) can only lead to worse outcomes.
Pharmaceutical companies have long complained about the strict regulations and long drug approval process that delay profits. And while some of their complaints have merit (there has been a longstanding need to reform and simplify clinical trials), the extreme caution existed for good reason: the protection of patients. For several years leading up to this, pharma companies, in response to patient demand and desire to speed up the timeline to launch new drugs, have been looking into innovative ways to improve the approval process — to make it faster, better and more convenient for patients; to use digital health solutions to recruit, educate, engage and guide patients; even to decrease driving times to participate in trials — but with this new law, that incentive is gone.
According to data gathered by the Center for Responsive Politics, an organization dedicated to checking campaign contributions, all together 420 organizations lobbied on this bill, including almost every major pharmaceutical. With the passage of the 21st Century Cures Act, pharma companies can use alternative evidence such as anecdotal case studies or reports in medical journals to prove drug efficacy and safety, instead of randomized clinical trials. The problem the Cures Act is trying to address — the length and cost of the clinical trials process — is a valid issue. However, it “shortens the process” by allowing circumvention, rather than encouraging innovation and streamlining of the gold standard. And the cost is patient safety.
As patients are also becoming increasingly reliant on digital health solutions, we are at a new frontier in digital health — where digital solutions won’t just solve wellness problems, but can provide a “personal digital doctor,” which will monitor patient conditions at home and make therapeutic recommendations. The new law allows certain types of digital health tools to also circumvent FDA scrutiny. These should go through the same approval processes that a novel drug goes through, not only to determine efficacy and safety, but to help patient and providers sift through the hundreds, if not thousands of apps claiming to address patients’ ailments.
Right now, the overwhelming number of solutions, combined with little oversight over their efficacy, is leaving providers, patients and caregivers to struggle with determining which solutions to use. We need to set the bar higher — we aren’t building solutions to share breakfast pictures, we're aiming to improve the health of those with chronic disease! Digital health solutions need to go through as many regulatory approvals as possible, to build credibility and to separate the “snake oil” from those that truly advance health outcomes.
While the 21st Century Cures Act will enable treatments, some life saving, to get through approvals quicker, it also increases the risk that patients adopt when using such drugs, medical devices or digital health tools. Yes, there were times when the FDA was a barrier, but it stood as an important liaison between pharma and medical device companies trying to make a profit, and patients desperate for an effective treatment. The 21st Century Cures Act would better serve patients if it had focused more on improving and reforming the drug and medical device approval processes, instead of weakening them.
About The Author:
Jonathan Chen is executive VP at digital healthcare consulting firm Medullan. Jonathan focuses on business strategy, planning operations management, and product development. He graduated from Stanford University with a bachelor's degree in biological sciences and computer science.