21st Century Cures Initiative Introduces Significant Legislative Proposal

In April 2014, Energy and Commerce Committee Chairman Fred Upton (R-MI) partnered with Rep. Diana DeGette (D-CO) to launch the 21st Century Cures initiative with an important goal: to accelerate the discovery, development, and delivery of new treatments and cures for patients. Over the course of nearly a year, patients, providers, innovators, regulators, and researchers from around the country provided a wide range of specific ideas on how Congress could help. Yesterday, the House Energy and Commerce Committee took a major move forward by releasing an initial discussion draft of the 21st Century Cures Act, which outlines many of the promising legislative proposals, drafted by both Republicans and Democrats.

It has been reported that among the 10,000 known diseases, 7,000 of which are considered rare, there are treatments for only 500. According to Dr. Francis Collins, Director of the National Institutes of Health (NIH), it now takes “around 14 years and $2 billion or more” to develop a new drug and “more than 95 percent of [such] drugs fail during development.” The 21st Century Cures Initiative has spent a year building a solution to this problem. Their draft is broken down into five key sections, which address the following priorities:

(1)    Putting patients first by incorporating their perspectives into the regulatory process and addressing unmet needs

“Patients are ultimately at the core of this initiative,” the Energy and Commerce Committee states. “A series of proposals are included in Title I to empower patients and foster an economic and regulatory environment more conducive to addressing their unmet needs.” This section includes policies on patient focused drug development, biomarker qualification, antibiotic drug development, dormant therapies, and innovative device review pathways.

(2)    Building the foundation for 21st Century medicine, including helping young scientists

“Leveraging recent advances in science and technology, researchers have uncovered new ways to proactively diagnose and treat patients in a more precise manner based on their unique set of circumstances,” states the Committee. Title II includes a series of proposals intended to help aid in the discovery, development, and delivery of the next generation of patient-centered solutions here in the United States, by establishing the 21st Century Cures Consortium, fostering innovation in health information technologies through the SOFTWARE Act, and helping young scientists.

(3)   Streamlining clinical trials

Legislation in Title III seeks to address the often-criticized trend towards increasing time and cost involved in conducting clinical trials in the United States. “By reducing regulatory overlap and administrative inefficiency, in addition to encouraging broader utilization of efficient, flexible trial designs, provisions in Title III would help modernize the development and assessment of potential new treatments and keep clinical trials from moving overseas by improving the cost and speed of trials,” notes the Committee.

(4)    Accelerating the discovery, development, and delivery cycle and supporting continued innovation at NIH, FDA, CDC, AND CMS

Title IV includes a wide-ranging series of proposals intended to streamline regulatory processes and equip federal public health agencies with the tools needed to ensure they are able to keep pace with innovation. “To help address the various issues that have contributed to this unacceptable bottleneck, a biomedical working group would be established to make recommendations on how scientists in this country can spend more time finding cures and less time filling out paperwork,” states the Committee. Title IV also includes a series of proposals that would streamline various regulatory processes for new vaccines. Further, Title IV incorporates the hard work of the bipartisan telemedicine working group and will set the stage  for new technologies to play a greater role in the delivery of quality health care services to Medicare beneficiaries. Exemption of CME and reprints from Sunshine Act reporting is also listed in this section (see page 344). 

(5)    Modernizing medical product regulation

Finally, Title V consists of policies developed to encourage modern manufacturing technologies here in the United States as well as provisions intended to update certain medical device regulations.

View the Energy and Commerce Committee’s 7-page White Paper on the 21st Century Cures Act: Probably the best starting point for working through this massive document.

View a section-by-section of the discussion document here: The Energy and Commerce Committee lays out each legislative proposal with a brief description – a much more user friendly version than the whole bill.

View the 400 page first release of legislative ideas here.

View a one-pager highlighting the legislative ideas here.

As the legislation moves through the process, Committee Chairman Fred Upton (R-Mich.) notes “everything is on the table, as we hope to trigger a thoughtful discussion toward a more polished product.” The committee requests specific feedback from all interested stakeholders about how to improve the legislation. Submit your specific suggestions to cures@mail.house.gov or contact committee staff with any questions. “The committee will 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,” the Committee notes. “The inclusion of a policy in this draft should not be seen as an endorsement.”

Updated, 1/28/2015, 10:00 am:

Democrats, including Rep. Degette and U.S. Rep. Frank Pallone (D-NJ) expressed varying levels of enthusiasm for the draft.

DeGette issued the following statement after Upton released potential proposals that have been submitted for inclusion in the 21st Century Cures initiative, which Upton and DeGette have been leading:

“From the beginning of the 21st Century Cures initiative, Chairman Upton and I have paid special attention to public engagement, idea-sharing, and feedback. In that vein, I appreciate his effort today to publicly share possible legislative language on a number of proposals that might be included in an eventual bill. As Chairman Upton and I begin to draft the bill itself, we look forward to receiving feedback on the issues identified in his draft document and other suggestions. While I don’t endorse the draft document, I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures.”

Pallone, Ranking Member of the House Energy and Commerce Committee, stated in a Press Release: “I am disappointed that the discussion document released today by Chairman Upton does not reflect true bipartisan collaboration.” He continues:

“In its current form, I am concerned that the nearly 400 page draft could create more problems for our health care system than it solves.  Further, the draft does not include any real dollars to fund additional basic research at the National Institutes of Health. Increased funding was a common theme during last year’s public engagement, from both sides of the aisle, and is fundamental to truly advancing 21st century cures. 

“Moving forward, I stand ready to work with Chairman Upton, and all Members of the Energy and Commerce Committee, to find bipartisan consensus legislation that would pass the House and the Senate and ultimately be signed by the President.”


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