Originally Published IVD Technology November/December 2003
INDUSTRY NEWS
FDA working on new ASR rulesFDA is planning to draft a new proposed rule on analyte specific reagents (ASR). FDA officials discussed this matter in a presentation on ASRs during a Webcast sponsored by the American Association for Clinical Chemistry (Washington, DC).
"FDA has concluded that genetic tests may not be unique in terms of having a risk profile that might warrant additional oversight through changes in the ASR rule," said Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health. "As a result, the agency is working on a notice of proposed rule making. This is a preliminary notice to precede any more-definitive new ASR regulations and is intended to allow various stakeholders an opportunity to put concerns and suggestions on the table."
Officials recognized that such a proposed rule is needed, considering one of the biggest areas of abuse in ASR testing may be the rampant marketing of finished devices as ASRs. At the same time, while additional rules may not be necessary to remedy the entire problem, clarification of the current rules may be needed, based on the different regulatory tools available under the Clinical Laboratory Improvement Amendments (CLIA) and FDA. Meanwhile, FDA does not plan to exert regulatory authority over home-brew tests, even though it is thinking about increasing its regulation of the ASRs used as essential ingredients for in-house tests.
"While this is a high-priority work item, it is also a very complicated issue and will take some time to sort through," says Gutman. "It is impossible to predict how this might sort out.
Much of the impetus for considering change in the ASR regulations came as a result of recommendations by the Secretary's Advisory Committee on Genetic Testing (SACGT). This group recommended risk-based changes in regulation that would be nonchilling for new technology, that would emphasize transparency in information over rigid data requirements, and that would be informed by interaction with key stakeholders, including professional groups. The SACGT recommendations were based on concerns that there were regulatory gaps between the oversight provided by FDA and CLIA. This is currently under review."
FDA officials have not indicated when the proposed rule will be released. "I do not know when or exactly in what form FDA will address the ASR issue," adds Gutman.
Industry analysts agree that the time is right for a new ASR regulation.
"FDA will need to clarify the definition of an ASR within the context of home-brew test development," says Thomas M. Tsakeris, president of Devices & Diagnostics Consulting Group Inc. (Rockville, MD). "That is, FDA will need to make clear how it will deal with situations where a manufacturer offers a primary reagent as an ASR and then separately offers the laboratory other proprietary secondary reagents and other components, such as buffers and control calibrators, that would ordinarily be needed to comprise a complete test kit or system, thus having the appearance of circumventing FDA premarket review."
Other analysts believe that FDA needs to release the new ASR rules before it is too late.
"The ASR rule is ripe for review," says Glen Freiberg, vice president of regulatory, quality, and government affairs at Gen-Probe Inc. (San Diego). "Innovation and experience have both contributed to this opinion. For example, FDA specifically targeted multianalyte products like arrays in its recent multianalyte draft guidance. However, it appears there is still some industry confusion on the subject. My feeling is that FDA also recognizes that some clarification on ASRs is appropriate and prudent. If no action is taken, FDA review could potentially be excluded from a whole new generation of diagnostic product review."
More information on ASRs may be found in the "Regulations and Standards" column.
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