Life Sciences: A New Opportunity for Innovation

When most people hear that Congress is working on health care legislation, they immediately assume we are in for another politically charged and polarizing debate.  However, history shows that when it comes to improving the ability of our nation’s pharmaceutical and medical device manufacturers to bring safe and innovative products to patients, Congress can come together and work in a bipartisan fashion to craft meaningful legislation.

With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, the Energy & Commerce Committee proved this yet again.  In fact, the Committee has passed dozens of bipartisan bills since the 112th Congress began in 2011. However, this was the first major piece of healthcare legislation developed by the Committee under the stewardship of Chairman Fred Upton (R-MI), and the first attempt at significant health care legislation since the passage of the Affordable Care Act.

After assuming the Chairmanship at the end of 2010, Chairman Upton helped lead the negotiations for meaningful reform of the FDA and reauthorization of its user free programs. Early in the process, he made it critical that all stakeholders – patients, providers, and manufacturers – were provided with the opportunity to engage in the legislative process, and the final package reflected the Chairman’s commitment to public input and bipartisanship. Since its enactment, the bill has been lauded by the life-science industry, patients, and regulators alike.

Now, Chairman Upton has partnered with Congresswoman Diana DeGette (D-CO) to provide a new opportunity for public and private stakeholders, in an effort to improve the health of people worldwide, to participate in an effort to shape the future of the regulatory ecosystem in which they exist.

On April 30, 2014 Upton and DeGette announced the “21st Century Cures” initiative, which will focus on three key areas to help advance the pace of medical innovation in the United States: discovery, development, and delivery. By examining these areas, Upton and the Committee hope to bring this country’s technological advances to bear on the regulatory frameworks impacting innovation in the life-sciences sector.

During his career on the Energy & Commerce Health Subcommittee, Chairman Upton pushed for a greater emphasis on biomedical research to improve the public health. It should be no surprise then that Upton is looking to work with the National Institutes of Health (NIH), FDA, and other agencies and stakeholders in this effort in order to encompass the full scope of the treatment development pipeline, from research funding to postmarket outcomes data.

On May 6, the Committee hosted NIH Director Dr. Francis Collins as well as Dr. Jeff Shuren and Dr. Janet Woodcock, heads of FDA’s drug and device regulatory centers, as part of a roundtable to discuss the 21st Century Cures Initiative with other stakeholders from various corners of the healthcare world. The Committee heard about the need for Congress to provide a more reliable funding stream to stabilize grants for long-term research projects. Various methods were also discussed to improve product approvals such as streamlining clinical trials, developing trial networks, expanded use of registry data, and incorporation of EHR into clinical trials. Several panelists also noted the challenges of receiving reimbursement for new products under the Medicare fee schedule, saying it inhibits innovation. These comments reflected the cross-cutting approach the Initiative has, and Chairman Upton’s track record on similar undertakings, as exemplified by FDASIA, give it the credibility to draw significant interest from the innovator community.

We can expect the Committee to continue this robust, public discussion through more hearings and roundtables this summer and fall.  In addition, they have already released three white papers outlining their ideas on specific issues and I expect more to come – each one presenting stakeholders an opportunity to publicly comment on these ideas.  Along the way, Chairman Upton has made it known that nothing is off limits, and no idea is too big or too small.

In conclusion, the life-science community has a unique opportunity with Chairman Upton and Diana DeGette’s 21st Century Cures Initiative to meaningfully impact the regulatory environment for future product development that meets the needs of patients today and tomorrow.    This initiative has the makings of something groundbreaking, and given Chairman Upton and the Energy & Commerce Committee’s track record of tackling big problems, the entire health care community should be paying attention.

 

Jeffrey J. Kimbell is the founder and President of Jeffrey J. Kimbell & Associates, a Washington-based consulting firm. Kenneth L. Hodge is an Associate Director of Government Affairs & Legislative Policy with the firm.

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