Washington, D.C. – Yesterday, Congressman Michael C. Burgess, M.D. (TX-26) introduced two health care bills that will foster innovation and lead to job creation and growth. The Cultivating Scientific Expertise to Foster Innovation for Patients Act, H.R. 3206, and the Modernizing Laboratory Test Standards for Patients Act, H.R. 3207, are aimed at loosening excessive regulations on American manufactures and laboratories. The Energy and Commerce Committee prepared this memo summarizing the committee’s findings and the ten legislative solutions, two of which are the bills Dr. Burgess introduced.

The Cultivating Scientific Expertise to Foster Innovation for Patients Act, H.R. 3206
"We have the technology to save and improve lives, but the restrictions that currently exist prohibit these medical innovations from reaching doctors and patients because of the current state of the FDA,” said Dr. Burgess.

We need to improve the FDA process for the products they do regulate and that is why we need to ensure the most qualified experts are available to the agency. In the important task of evaluating products that can improve the health of American patients, we want the best of the best.  Setting arbitrary waiver limits not only clogs the already overwhelmed FDA process, but encourages membership by lesser qualified individuals. In the arena of life-altering medical treatments, this is unacceptable. Long delays due to vacancies and panels with lesser qualified members put lives unnecessarily at risk.

The Modernizing Laboratory Test Standards for Patients Act, H.R. 3207
“It is important that we relieve restrictions while providing regulatory reform that positively impacts and protects patients while promoting job growth,” said Dr. Burgess.

Adding additional and duplicative FDA regulations to industries that are not under the agency’s jurisdiction will further burden an overstretched institution that cannot currently process their substantial backlog due to their own regulations being a hindrance. The Modernizing Laboratory Test Standards for Patients Act will provide clear regulatory certainty, foster innovation, save American jobs, and ensure patients have access to the breakthrough medical products of tomorrow. The Modernizing Laboratory Test Standards for Patients Act has already been well received:

"On behalf of Laboratory Corporation of America Holdings ("LabCorp") and its 31,000 employees nationwide--including almost 2,500 here in Texas--I would like to thank Congressman Burgess for his leadership in authoring legislation to provide a CLIA-based approach to the oversight of laboratory developed tests. The clinical laboratory testing industry is one of the most versatile and sophisticated functions of the health care system, making advances everyday to improve patient outcomes and eliminate unnecessary and ineffective care. We at LabCorp strongly support his bill, which would modernize and strengthen the existing CLIA program, providing greater protections for patients, without slowing down innovation in our laboratory right here in Dallas and hundreds of others nationwide. We look forward to working with Congressman Burgess in the coming months to help enact this important legislation." --Bob Nelson, Senior Vice President of Operations, Laboratory Corporation of America Holdings

"Representative Burgess, on behalf of Quest Diagnostics and our over 860 employees at our Irving, Texas, laboratory, we thank your for your leadership and stewardship of patients' access to quality, affordable health care by your introducing legislation for a CLIA-centric approach to the oversight of laboratory developed tests, which are at the forefront of medical breakthroughs. We offer you our full support for this important effort, which will benefit hundreds of thousands if not millions of patients nationwide and allow clinical laboratories to continue to develop new tests to improve patient health as well as enable economic growth." --Michael Peat, Ph.D., Managing Director, Texas Gulf Coast Business Unit

Alan Mertz, President of ACLA said, “This bill reflects the need for government regulation to keep pace with the advancements in science that will move our health care delivery system to one focused on what is best for the patient, public health, and the economy.  In particular, we note the legislation’s effectiveness in reaching these goals by strengthening the current regulatory structure and eliminating duplicative regulation; enhancing public transparency for patients, providers and regulatory agencies; and strengthening reporting for adverse events—all without additional government expenditures.”