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ACR applauds FDA Reauthorization Act of 2017, initiatives to quicken biosimilar approvals
In a statement from Sharad Lakhanpal, MBBS, MD, president of the American College of Rheumatology, the group applauded the enactment of the FDA Reauthorization Act of 2017.
“Expanding our patients’ access to safe, effective, and affordable biologic and biosimilar therapies is a top priority of the rheumatology community,” he said. “Therefore, the American College of Rheumatology applauds new legislative and regulatory developments that will expedite the approval of new therapies, increase competition and lower the cost of these drugs.”
Both chambers of Congress passed the bill with bipartisan support. The bill re-authorizes the FDA’s user fee agreements for prescription drugs, generic drugs, medical devices and biosimilars for an additional 5 years. Funds from this user free program will aid the FDA to market new biosimilar therapies quickly and safely, according to the statement.
The American College of Rheumatology also applauded FDA Commissioner Scott Gottlieb for starting a new hiring program that coincides with principles from the 21st Century Cures Act that permits the FDA to “on board experts in the regulation and approval of biosimilars.”
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