Washington, D.C. – Congressman Michael C. Burgess, M.D. (R-TX), vice-chairman of the House Energy and Commerce Subcommittee on Health, today issued the following opening statement, as prepared for delivery, at a hearing titled, “21st Century Cures: Modernizing Clinical Trials”:

“This country has set the gold standard for clinical trials; specifically, the rigorous investigative approach we require.

“However, that does not mean the bar cannot be raised to keep up with emerging science and new techniques in investigational review. 

“Failure to adapt could turn what was once considered the standard of excellence in regulation into an antiquated and out of touch system with the field it applies.

“One needs look no further than personalized medicine and the human genome for an example of this. We are approaching a time when treatments could be tailored for a person’s specific genetic code. 

“There is no way such a revolutionary approach to treatment could be evaluated in the same way as a single molecule drug meant for large populations.

“I appreciate the subcommittee asking the question: How can we build in more flexibility and innovation into the trials process so that these just-over-the-horizon therapies can make their way to patients?

“While these changes must always ultimately retain the integrity needed to ensure the end product is safe and effective, we cannot be caught off guard and risk watching innovative therapies suffocate at the hands of a regulatory system that has not kept up.”

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