Subcommittee examines clinical trials process for medical therapies

Rep. Michael Burgess (R-Texas) said on Wednesday that a system must be put into place to ensure new medical products are safe and effective without the regulatory system stifling innovative medical breakthroughs.

Burgess, the vice chairman of the House Energy and Commerce Subcommittee on Health and a physician, delivered his remarks at a hearing of the subcommittee entitled, “21st Century Cures: Modernizing Clinical Trials.”

“This country has set the gold standard for clinical trials; specifically, the rigorous investigative approach we require,” Burgess said. “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 the regulatory system, Burgess said, could turn the “gold standard” into an antiquated regulatory program that’s not in touch with the medical community.

“One needs look no further than personalized medicine and the human genome for an example of this,” Burgess said. “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.”

Burgess said finding ways to build more flexibility and innovation into the clinical trials process to ensure that cutting-edge therapies succeed must be a priority of the subcommittee.

“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,” Burgess said.