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ACR supports Biosimilar User Fee Act renewal in testimony to the FDA
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In a public meeting held in Washington, D.C. by the FDA, the American College of Rheumatology testified in support of reauthorization of the Biosimilar User Fee Act.
The Biosimilar User Fee Act (BsUFA) gives FDA the authority to assess and collect fees from pharmaceutical companies related to their biosimilar products in order to expedite the review process for approval of these products.
Angus B. Worthing, MD, FACR, FACP, a practicing rheumatologist and member of the American College of Rheumatology (ACR) Government Affairs Committee, was invited by the ACR to testify.
According to a press release, Worthing told the committee, “We know that at least one in six people with rheumatoid arthritis already reduce their medication due to cost, potentially resulting in long-term joint damage. We physicians are extremely frustrated when we see our patients suffer because they cannot obtain or use the medicines as we have prescribed or as recommended by the FDA. We hope the anticipated decrease in cost resulting from the introduction of safe and effective biosimilars will increase access to these agents and improve the health of all who use them.”
According to the release, the ACR also asked the FDA to “make prompt and careful review of look-alike and sound-alike proprietary names and packaging labeling” to increase transparency for patients and physicians, particularly related to the way biosimilar medications are named.
“This increased transparency will not only reduce medication errors, but also increase prescriber confidence in biosimilar safety and efficacy data, allowing for more extensive and robust pharmacovigilance programs,” Worthing said in the release.
The current BsUFA is set to expire in September 2017.
Reference:
www.rheumatology.org.