2011-06-10

The Food and Drug Administration (FDA) recently released a draft guidance document, "Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions," and is soliciting public comments. ASH has recently heard from several hematopathologists who raised concerns about possible negative effects this guidance could have on laboratory diagnostics.

The draft guidance, if enacted, will effectively ban the manufacturers from selling any reagents labeled as “research use only” (RUO) to any laboratory that they know or have reason to believe may use them in a clinical test. While this would not be expected to affect most routine laboratory tests, it has the potential to cause major disruptions for molecular diagnostics laboratories. A vast majority of these laboratories use “lab-developed tests,” in which some of the components are RUOs.

The FDA believes that this guidance will lift the burden from the laboratories and potentially improve patient safety by ensuring that the manufacturer performs the appropriate quality control measures on RUOs as a prerequisite of relabeling and FDA re-approval. One of the main concerns that the hematopathology community expressed is that the manufacturers will not make these reagents available in the short-term if this guidance is enacted without appropriate phase-in time period. Moreover, limited availability of these reagents could greatly delay the development of novel diagnostics, for even if the reagents could be used for research purposes, translation to the clinic would not be possible until all the reagents were relabeled.

The public comment period is open until August 29, 2011. ASH is working with its membership and several professional organizations to develop comments to the FDA. ASH encourages any members who have concerns about this draft guidance (including specific examples of how it could negatively affect hematology and potential alternative solutions) to share their comments by contacting ASH Government Relations Manager Stephanie Kaplan (skaplan@hematology.org or 202-776-0544).

back to top