Comments to FDA
The Biotechnology Industry Organization (BIO) raised issue with FDA’s definition of “research use” to mean “evaluate design, limited-scale performance, and issues such as usability of the test.” BIO has said that the definition is overly narrow and contrasted it to FDA’s 2007 ASR (analyte-specific reagents) Guidance, which includes in the definition evaluating potential clinical or informational usefulness of the test.
“BIO is concerned that the draft guidance lacks adequate clarity for implementation, and believes that certain provisions are inappropriate and inconsistent with applicable law and historic FDA practice,” Paul Sheives, director, diagnostics and personalized medicine policy for BIO, told the FDA.
He said that if the agency insisted on moving forward with new RUO and IUO rules, “FDA should proceed in a phased-in manner to allow time for companies to submit the required regulatory submissions to ensure that access to many important research tools and continued patient access to important clinical diagnostic information is not blocked.”
The Association for Molecular Pathology (AMP) said its members expressed fear that the guidance may prompt many manufacturers to avoid FDA review by withdrawing RUOs from the clinical market altogether. “This has already occurred for many analytes, from blood-borne pathogens to sexually transmitted diseases. This would then create a shortage of supplies to develop laboratory tests, resulting in a scarcity of tests and ultimately barriers for patients’ access to medically necessary tests,” Elaine Lyon, Ph.D., chair of AMP’s Professional Relations Committee, said in the group’s comment to FDA.
A Merck & Co. executive told FDA the draft guidance also affects drug and biologics manufacturers, which make extensive use of IVD tests in R&D. “We urge the agency to draft a separate guidance document(s) to address use of RUO or IUO diagnostic tests in drug and biologic R&D activities as well as how the current guidance might affect a manufacturer using an RUO or IUO diagnostic test that subsequently could be regarded as misbranded,” Ekopimo Ibia, Merck’s director and U.S. regulatory policy lead, told the FDA.