Speaking of Health – How the 21st Century Cures Act Impacts Healthcare Communications

July 10, 2015

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The pace of change in healthcare is breathtaking. There are new ways to treat, new ways to research, new ways to pay for care, new ways to access care and new ways to communicate about it. Yet, in too many ways, the way we, as a nation, regulate remains a 20th century model plagued by delays and red tape. Incremental change is not enough to keep up with the dynamism that is the healthcare sector. Instead, milestone legislation has to address broad and sweeping reform.

Rarely does a proposed bill touch upon nearly every aspect of healthcare. But this week the U.S. House of Representatives has passed H.R. 6, more popularly known as the 21st Century Cures Act (the “Act”), a sweeping piece of legislation that addresses wide-ranging aspects of how we go about getting new medicines from test tube to patient and touches just about every stakeholder in the process.

A lot has been written about this bill and, during its passage in the House, there were many efforts to amend it with new provisions. But it has emerged with rare bipartisan support. In a nutshell, the Act aims to get more treatments approved more quickly and reaching patients more efficiently by:

  • Providing new funding for biomedical research
  • Being more inclusive for new, innovative approaches
  • Requiring the National Institutes of Health (NIH) to offer a research strategic plan
  • Widening the research lens on rare and pediatric conditions
  • Further expediting the Food and Drug Administration’s (FDA) means for approving new compounds.

How does it get there? There are several new mechanisms to achieve these ends. The Act would put into place new policies about expanded access programs that explain the ways patients can obtain treatments still under investigation; new guidance from FDA about how companies can communicate information about medicines to the public; embracing Bayesian adaptive clinical trial design (clinical trials that adapt to patient information as they go along) in drug investigation; expanded use of medical apps and establishing a greater role for Telemedicine in providing care.

That is the short list. The Act is several hundred pages and would require a series of blog posts to digest in detail.

But what becomes clear is this: The Act is introducing or elevating a whole range of terms and practices with which most people aren’t that familiar, even many of those experienced in various aspects of health care. On top of that, there are a vast number of stakeholders involved – from pharmaceutical companies and device manufacturers to insurers to patient organizations to providers to researchers.

What is a Bayesian adaptive trial and how would it make a difference? How do you explain it to someone? What are expanded access programs? How does Telemedicine work? What apps are regulated and which are not?

Not only do terms need to be defined, but context needs to be provided. How does one explain an adaptive clinical trial without explaining how clinical trials are done now, or how expanded access will change the status quo?

As we saw with the passage of the Affordable Care Act, major reform ushers in a whole new vocabulary and can create confusion. Left unattended, we could see misunderstanding, misinterpretation and even fear. The bill has met with success in the U.S. House of Representatives and, as the initiative now passes to the Senate, it is important we take the time to understand the vernacular, the context and be prepared to deliver for all the stakeholders affected by the 21st Century Cures Act, whether we are public relations professionals, pharmaceutical or device companies, medical societies, government agencies or patient organizations.