House Energy and Commerce Committee Embarks on Effort to Identify Path to 21st Century Cures
On May 1st of this year, The Chairman of the House Energy and Commerce Committee, Rep. Fred Upton (R-MI), and the Ranking Member of the Committee, Diana DeGette (D-CO), announced an ambitious bipartisan initiative entitled “21st Century Cures”. The fundamental premise underlying the effort is the belief that while health research is progressing rapidly, “the federal drug and device approval apparatus is the relic of another era.” According to Reps. Upton and DeGette “If we want to save more lives and keep this country the leader in medical innovation, we have to make sure there’s not a major gap between the science of cures and the way we regulate these therapies.”
Accordingly, the Committee is committed to undertaking an unprecedented and comprehensive evaluation of what steps can be taken to accelerate the pace of cures in America. To this end, the Committee intends to examine “the full arc of this process—from discovery of clues in basic science to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase.”
As part of this effort, the Committee is preparing white papers on various dimensions of the issue, calling for commentary on those papers, and conducting numerous hearings and roundtables to hear the views of a wide range of experts and stakeholders. The Committee is also actively “soliciting ideas on how Congress can help accelerate the discovery, development, and delivery of promising new treatments to patients”.
White Papers and Hearings to Date
So far the Energy and Commerce Committee has prepared one white paper, held six hearings, and convened two round table discussions. What follows is a summary of those proceedings.
The first white paper is entitled “21st Century Cures: A Call to Action.” It posits several issues of interest to the Members of the Committee including:
- how to ensure that the United States remains the world leader in medical innovation
- how the country can incentivize, coordinate, and accelerate research on rare diseases and conditions
- how advances in translational research, health information technology, and communications can be leveraged to facilitate new cures
- what can be done to address the increasingly burdensome costs and regulatory burdens of clinical trials
- with the average cost of developing a new drug now exceeding $1 billion, what policies should be pursued to encourage robust drug development
- how the power of the Internet and social media can be harnessed to foster medical innovation and the dissemination of critical information to patients and health care providers.
The first 21st Century Cures hearing was held on May 20th by the Subcommittee on Health of the House Energy and Commerce Committee and was entitled “21st Century Cures: The President’s Council of Advisors on Science and Technology (PCAST) Report on Drug Innovation”. This proceeding examined a report ordered by President Obama on the topic “Propelling Innovation in Drug Discovery, Development, and Evaluation”. Witnesses at the hearing included experts who were involved in the preparation of the PCAST recommendations which included, among other things:
- supporting Federal initiatives to accelerate therapeutics
- catalyzing the creation of a broad-based partnership to accelerate the pace of therapeutic innovation
- expanding the Food and Drug Administration’s existing authorities for accelerated approval and confirmatory evidence
- creating a new pathway to initial approval of drugs shown to be safe and effective in a specific subgroup of patients
- improving FDA’s tools for monitoring and communicating clinical benefits and risks
A second hearing was conducted by the Subcommittee on Health on June 11th on the topic “Examining the Role of Incentives in Advancing Treatments and Cures for Patients”. The Subcommittee took testimony from numerous witnesses on whether existing economic and regulatory incentives are adequate to encourage robust investment in advances in drugs and devices especially for those patients who have unmet medical needs.
The need to modernize clinical trials was addressed at a hearing by the Health Subcommittee on July 9th and included witnesses from the Yale Cancer Center, the Mayo Clinic, Johnson & Johnson, and the Medical Device Innovation Consortium. The purpose of the hearing was to ascertain whether there are ways “to make trials more efficient and effective by leveraging recent advances in science and technology.”
Patients were afforded an opportunity to express their views on the discovery, development and delivery of treatments at a Subcommittee hearing on July 11th. Witnesses from organizations such as the Cystic Fibrosis Foundation, the Parent Project Muscular Dystrophy, the American Cancer Society, and the National Organization for Rare Diseases testified.
A joint hearing on July 17th by the Subcommittee on Communications and Technology and the Subcommittee on Health was captioned “21st Century Technology for 21st Century Cures” and, among other issues, considered ways to leverage the expertise of technology companies to “allow health researchers and clinicians to more efficiently share data and communicate”. Representatives of Amazon, Qualcomm, LyfeChannel, Health Fidelity, and McKesson Connected Care appeared at the hearing.
The Subcommittee on Health hosted a hearing on July 22nd entitled “Examining Barriers to Ongoing Evidence Development and Communication” which, according to the Subcommittee, was intended to “focus on issues surrounding continued evidence development of information regarding treatments and cures in the real world setting”. Specifically, the Subcommittee was interested in investigating how data sharing and “enhanced learning” “…through the Internet, social networks, or other platforms” “should be facilitated among doctors, patients, researchers, and scientists” to promote “the free flow of data, research, and results.” Witnesses from the Health Leadership Council, Edwards Lifesciences, the Pew Charitable Trusts, ADVI, and the Alliance for Specialty Medicine appeared at the hearing.
In addition to the formal hearings, the Subcommittee has conducted two roundtables—one on May 6th on the 21st Century Cures initiative and one on June 24th on digital medicine.
What Does This Mean?
As the summary above makes clear, the 21st Century Cures initiative is a serious effort by key lawmakers to develop a comprehensive approach to accelerate the pace of cures in the United States. Chairman Upton has indicated that after the Committee completes its hearings and roundtables, it will prepare a legislative proposal which will incorporate the findings and recommendations of the Committee. It is possible that a white paper or proposed recommendations will be issued later this year with a legislative proposal to follow in the next Congress. In any event, this is an effort that warrants close attention by all who have an interest in drug and device development, whether personal or professional.
The Committee has done an outstanding job of making detailed information on the 21st Century Cures project available to the public through their website. You are encouraged to follow this effort closely as further hearings and possible recommendations unfold later this year.
About the Author
George G. Olsen, Esq. became a principal at the law firm of Williams & Jensen, PLLC in January of 1978 and was elected President of the firm in 2004. For nearly 35 years, Mr. Olsen’s primary concentration has been health law, representing pharmaceutical and biotechnology companies, health insurance and managed care organizations, hospitals and other health care providers, as well as businesses affected by federal health care law. Mr. Olsen has expertise in legislation, regulations, and policy matters in the health care sector and has been involved with virtually every major health care legislative initiative over the last three decades.