21st Century Cures’ Legislative Goals: Clinical Trials Improvements, Regulatory Modernization
January 29, 2015
by Amanda Conschafter, blog editor
This week the House Energy and Commerce Committee released a formal ideas statement to spur legislative action on its 21st Century Cures initiative. Reflecting 19 roundtable events, eight legislative hearings, and five white papers, the document marks the first step in the initiative’s legislative process. Suggested aims for legislation include incorporating patient experiences into the regulatory process, encouraging young scientist, and modernizing clinical trials for faster access to breakthrough therapies.
The brainchild of Energy and Commerce Committee Chairman Fred Upton (R-MI) and committee member Rep. Diana DeGette (D-CO), 21st Century Cures launched in April 2014. The initiative seeks to accelerate the pace of cures and medical breakthroughs in the United States.
Since its launch, 21st Century Cures has taken a broad look at the scope of cures and medical breakthroughs. Roundtables sought a wide range of insight, inviting input from patients and their advocates, researchers, representatives from federal agencies, and others.
The pathway to 21st century cures, the initiative has revealed, requires several forms of modernization. The initiative’s ideas statement cites the need to secure the medical product supply chain, incentivize manufacturing, and subject controlled substances exportation to fairer regulation. The initiative also looks to accelerate cures innovation at federal agencies, including the National Institutes for Health, the Centers for Disease Control, the Food and Drug Administration, and the Centers for Medicare and Medicaid Services.
Beyond modernizing systems and agencies, the initiative looks to increase the role of additional stakeholders. The ideas document cites encouraging young scientists and incorporating patients’ experiences into the process as key goals.
And the initiative gives attention to another key area of modernization required for 21st century cures: modernizing clinical trials. As the precursor to approval for breakthrough medicines, clinical trials determine how many new cures are available to patients – and how soon.
In addition to streamlining, as suggested by 21st century cures, the trials process could also improve through heightened public awareness. As the Coalition for Clinical Trials (of which the Alliance for Patient Access is a member) notes, many Americans don’t fully understand the concept or value of a clinical trial. Thus, many clinical trial sites fail to enroll the number of participants needed to proceed.
As U.S. legislators face a myriad of policy priorities for 2015, the 21st Century Cures initiative strives to have its goals noticed. The initiative plans to “continue on an aggressive schedule to introduce 21st Century Cures legislation and ultimately send a bill to President Obama’s desk for signature by the end of the year.”
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