The 21st Century Cures Act, an ambitious bipartisan bill primarily designed to advance medical science and accelerate the introduction of innovative therapeutics to market, cleared the Senate Wednesday after being overwhelmingly passed by the House last week. The next step up is President Obama’s desk, where it’s almost certain to gain the final seal of approval.
The Cures Act is a complex, sweeping bill—maybe too sweeping. It takes a bit of digging to fully comprehend potential impacts of new funding for initiatives that run the gamut from cancer to drug addiction to Lyme disease and everything in between—with a solid dose of health IT promotion thrown in for good measure (although health IT is not specifically funded in this bill).
Many types of businesses and organizations could potentially benefit and it is expected (and hoped) to exert a positive impact on the treatment of a variety of diseases. Which stakeholders are positioned to gain the most? What’s the downside? What are some precautions to be aware of? And, finally, will the majority of U.S. taxpayers realize a positive ROI?
The important common themes and raisons d’être running through the Cures Act to consider are that:
- We need to promote R&D while streamlining complex and often duplicative processes associated with bringing drugs and devices to market.
- We need to be able to share health data more easily so that is can be put to work to advance the treatment of disease.
- We need patients to be more involved in their healthcare and health data, and industry needs to get on board with enabling that.
Through the Cures Act, money will be going to a lot of places across the healthcare ecosystem.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The obvious big market winners are pharma and medical device companies who should be able to translate more funding for biomedical research and streamlined approval processes into innovative new product offerings that drive sales.
Scientific research and healthcare delivery is increasingly dependent upon on digital tools like electronic health records and, particularly, advanced analytics and artificial intelligence, which is becoming so critical to R&D. Health IT stakeholders will ultimately benefit from improved connectivity due to the bill’s stipulations on improving interoperability, enhancing digital patient matching and promoting patient access to personal health data.
The bill also proposes a new health IT policy direction, emphasizing the need to lessen the burdens associated with Meaningful Use and other reporting requirements. But, a word of caution to all the clinicians struggling with EHR adoption who might have hoped that the Cures Act (along with potential repeal of the Affordable Care Act) will make it less imperative for them to use health IT: This bill further confirms the inevitability that the future of healthcare is digital. Get used to it.
Where’s the bad?
Well, the Cures Act definitely has its naysayers, chief among them progressive, left-leaning Sens. Elizabeth Warren (D-Massachusetts) and Bernie Sanders (I-Vermonth), who are uncomfortable with potential risks to patient safety that may accompany a faster track to market approval.
Other critics believe that the Food and Drug Administration doesn’t really need expedited approvals because the agency has already made important progress in this area and often brings drugs to market at a faster pace than other developed countries. An article in article in Health Affairs in July argued for a delay in passage of the Cures Act, pointing out that 60 percent of drug approvals in 2012 and 2013 took advantage of existing FDA expedited review programs.
Critics also don’t like that the Cures Act shifts funding away from some preventive health initiatives to pay for the development of more drugs and medical devices and point to the heavy, expensive lobbying efforts by manufacturers as indications that this bill is mostly about promoting a market bonanza for these companies.
What about benefits for consumers? Will the Cures Act transform the treatment of disease?
Maybe.
My take on the Cures Act is that it is mostly a win for the people. We can take comfort in a big spending bill that seeks to discover the causes and cures for disease.
Anyone who has personally faced a devastating illness or watched loved ones suffer can relate to the urgency to do this. We want effective and safe new drugs NOW! And while dissenters like Sanders and Warren decry the bill’s “big business” focus, quite frankly, the scale and complexity of what we need to accomplish to drive innovation and advance cures likely require a big business and coordinated approach.
There are definitely some potential risks to speeding up the development and approval of drugs, and we don’t want to go backwards by lowering standards that could compromise safety. But the risks are likely worthwhile. Further, I’d like to believe that by increasingly leveraging advanced IT systems — especially big data analytics and artificial intelligence — in product development, we can mitigate any increased risk.
Certainly, the world potentially benefits from American innovation and that’s good news for the global community.
But will U.S. taxpayers equally benefit from their investments, especially if their access to healthcare is threatened under Republican reforms? It would be most unfortunate if U.S. taxpayers end up subsidizing the development of innovative new medications for global markets that they themselves can’t afford.
Another issue worth pondering with this bill: Are we focusing on too much disease versus focusing on health? It’s unfortunate that the Cures Act takes money away from some preventive care efforts — although it will hopefully add some new preventive programs around opioid abuse.
We certainly need to focus on treating illness but that should not happen at the expense of focusing on health. In an ideal world, we do both. However, activities and programs that focus on health and wellness are generally not lucrative and are hard to commercialize, especially for big business.
Which brings up another issue.
What is the impact of promoting more technology on health system costs? We need to be concerned about this because technology breakthroughs, particularly related to innovation in drugs and medical devices, have not generally reduced costs or slowed medical inflation. In fact, it’s been quite the opposite.
Although there is some debate about this (the pharma industry points to the fact that more money spent on drugs saves money elsewhere in the healthcare system) the fact is that, often, there is no direct line between more money spent on technology and better health outcomes.
Unfortunately, the Cures Act does not address the elephant in the room of exploding drug prices — I’m looking at you EpiPen and Daraprim. It is only fair that we ensure that American consumers have the ability purchase all these wonderful new treatments that could emerge from the Cures Act. Healthcare industry stakeholders
Healthcare industry stakeholders should advocate strongly for a smooth transition in national health policy so that the largest amount people can take advantage of new taxpayer-funded products and services. And we all need to hold pharma and med device manufacturers’ feet to the fire on the issue of rising prices.
Photo: Flickr user Pete Ashton
