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Reauthorization of FDA user fee agreements will strengthen dialogue and advance innovation, Biotechnology Innovation Organization (BIO) Chief Scientific Officer Dr. Cartier Esham told the Senate Health, Education, Labor & Pensions (HELP) Committee in a hearing yesterday.
Reauthorization of the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act is important because they “ensure effective and timely reviews, improve drug and biologics safety monitoring, enable the Agency to keep pace with medical and scientific advancements, allow for earlier and more frequent FDA-sponsor engagement to identify and resolve drug and biologic development challenges, and provide the support necessary to ensure that advanced medicines are available to patients as efficiently and safely as possible,” said Dr. Esham in her opening statement.
PDUFA VII is “most critical to advancing innovation,” she continued, “enhancing and strengthening scientific dialogue between sponsors of applications and FDA,” especially around decentralized clinical trials and digital health tech, which moved forward during the pandemic.
Ranking Member Sen. Richard Burr (R-NC) asked: “What promise does the Accelerated Approval pathway provide for companies investing in novel treatments, and particularly treatments for rare diseases?”
“It is critical for continued investment in innovation in these disease areas that are complex and where there are little or evolving precedents,” Dr. Esham responded. “If it did not exist or it’s not able to function as intended, the path forward for timely access to improved care for these devastating diseases will be limited and delayed.”
