What you need to know

A recent FDA Warning Letter clarifies existing procedural requirements imposed on RDRCs.

What you need to do

Institutions should ensure that protocols are only approved at convened RDRC meetings—and consider holding these meetings more frequently—in addition to reviewing their procedures for obtaining IRB approval to make sure these determinations are communicated to the RDRC.

The FDA recently issued a Warning Letter to Columbia University citing several deficiencies related to the conduct of its Radioactive Drug Research Committee.  Institutions that intend to use radioactive drugs for research purposes are required to implement an RDRC to review this research.  The FDA regulations include specific requirements related to membership, quorum and approval processes.

Two citations in the FDA's Warning Letter to Columbia stand out because they clarify procedural requirements imposed on RDRCs.  First, the FDA made it clear that RDRCs are not permitted to approve research use of radioactive materials unless this approval is obtained at a convened meeting of the RDRC where a quorum of RDRC members is present.  While the FDA regulations permit RDRCs to meet on a quarterly basis, Columbia was cited because the RDRC approved research use of radioactive materials between these quarterly meetings.  Essentially, this warning letter appears to state that the RDRC is not permitted to conduct "expedited review" of protocols.  Institutions that conduct full meetings of their RDRCs only on a quarterly basis should be on notice that protocols cannot be approved between meetings—and they may wish to schedule RDRC meetings more frequently to avoid creating a backlog of protocols awaiting review.

The second notable citation in the Warning Letter relates to Institutional Review Board review.  The FDA cited Columbia's RDRC for not ensuring that all protocols being reviewed by the RDRC had already been approved by the institution's IRB.  The FDA regulations require that the RDRC's approval be contingent on the investigator also receiving IRB approval of the protocol.  The Warning Letter highlights a difficult "order of operations" problem for institutions, however.  Many institutions require approval by their RDRC before IRB approval can be granted, but this Warning Letter implies that IRB approval should be obtained first.  Institutions should review their processes to ensure that, at a minimum, the IRB's determination on any protocol where radioactive materials are involved is communicated to the RDRC.  Institutions may also wish to seek guidance from the FDA about the application of the Warning Letter's rules to their existing "order of operations" for research-related reviews.