North Texas News

Washington, D.C. - Congressman Michael C. Burgess, M.D. (R-TX), Chairman of the House Budget Committee Health Care Task Force, led a roundtable titled "Paying for 21st Century Cures: Examining the Budgetary Effects of Increasing Patient Access to Cell and Gene Therapies."

During the roundtable, Chairman Burgess examined the projected impacts on the federal budget as patient access to innovative cell and gene therapies continues to expand.

"We all know the healthcare struggle with budget issues. If we are ever going to move from where we are now to where we should be in the future, we have to somehow fix the budget. Modifying genetic material within the patient’s cells and developing personalized treatments were nonexistent before. We passed a big bill in 2016 [21st Century Cures Act], to accelerate new biomedical advancements. Leading up to that law being enacted, we held roundtables all over the country, discussions, and hearings for years leading up to actually passing the legislation and providing the funding for that research, and to streamline the approval process to foster collaboration.

I think we can look back to that success. And then the question becomes, what can we be looking forward to for future successes? Today was a crucial discussion in the licensing of gene therapy, regulatory hurdles, budgetary impacts, and potential policy solutions to build upon the 21st Century Cures Act," said Chairman Burgess during the roundtable.

Joining Chairman Burgess and Committee members at the roundtable were Chapin White, Director of the Health Analysis Division at the Congressional Budget Office (CBO); Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA); Dan Mendelson, Chief Executive Officer of Morgan Health; and Mike Capaldi, Executive Director of the Institute for Gene Therapies.

Background:

Unlike many existing medications where a single product is used to treat all patients, cell and gene therapies are personalized to a patient’s individual cells and genes. Due to their personalization, many cell and gene therapies have been able to overcome longstanding barriers in treating certain diseases. These therapies have very high upfront costs due to their complex nature but have potential long-term health care cost savings by curing or significantly reducing disease burdens. This poses unique budgetary challenges and opportunities for federal and state governments as well as private payers and individual patients.

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