BIO’s CSO testifies at congressional hearing on PDUFA riders

Legislation to modernize the clinical drug development paradigm should be patient-centric, effective and inclusive, BIO’s Chief Scientific Officer Dr. Cartier Esham told a House panel yesterday.

Some of Dr. Esham’s testimony can be seen in the video below. Her full prepared testimony is available here.

Dr. Esham testified at the U.S. House Energy & Commerce Subcommittee on Health hearing on The Future of Medicine: Legislation to Encourage Innovation and Improve Oversight, covering Prescription Drug User Fee Act (PDUFA) riders.

She and many committee members discussed the importance of FDA accelerated approval as a key pathway for innovative cures.

“If we want to have drugs approved that treat diseases before symptoms appear, it requires accelerated approval,” said Ranking Member Cathy McMorris Rodgers (R-WA). “I cannot support anything that undermines this important pathway.”

All witnesses supported the creation of ARPA-H—the Advanced Research Projects Agency for Health—a new agency under NIH to “improve the government’s capability to speed research,” Friends of Cancer Research’s Dr. Jeff Allen explained.

There was bipartisan support for improving clinical trial diversity—with Subcommittee Chair Anna Eshoo (D-CA) saying they’re considering bills that would require trials to report to FDA a diversity action plan and address barriers to participation, among others.

Dr. Esham also discussed antimicrobial resistance, calling it “one of the leading causes of death globally,” with “unique challenges” for drug development. “We urge enactment and passage of PASTEUR this year to … drive and sustain much-needed investment in this space,” she said.

Highlights from Dr. Esham’s testimony:

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