Members of the Blood Products Advisory Committee to the Food and Drug Administration convened for their 102nd meeting in Gaithersburg, Md., on May 15-16, to advise the FDA on the safety and effectiveness of the proposed OraQuick In-Home HIV Test, and evaluation of potential new plasma products manufactured following storage at room temperature for up to 24 hours.
The OraQuick In-Home HIV Test has been available for a number of years as a home sample kit for a test performed by a commercial lab. The current request before the FDA was to allow the test to be performed in the home. The committee was asked to consider the risk of false-negative and false-positive results; whether available data provide reasonable assurance that the test is safe and effective for its intended use; and any risk mitigation strategies that should be considered, as well as the labeling. The BPAC voted unanimously that the benefits of the in-home test outweigh the possibility of risks for consumers. The outcome of the BPAC vote was consistent with the position of approximately 25 health care professionals and HIV/AIDS advocates who addressed the committee in support of the decision.
NOTE: On July 3, 2012 the FDA approved the OraQuick In-Home HIV Test as an in-vitro diagnostic home-use test for HIV (HIV-1 and HIV-2) in oral fluid.
Device manufacturers (apheresis and whole blood) asked the FDA to consider whether plasma for transfusion manufactured either from whole blood or by apheresis could qualify for licensure when freezing does not take place for as long as 24 hours following storage at room temperature. For purposes of discussion at the BPAC meeting, the products were collectively termed PF24RT24. After much consideration, the committee focused its advice on clinical benefits versus potential risks rather than attempting to respond to specific questions concerning Protein S, which the committee determined was a less important issue. The vote was unanimous in favor of clinical benefit. The committee did not reach a consensus on whether any particular distinctions might be needed if PF24RT24 was to be relabeled "Thawed Plasma" with two members voting "yes," five abstentions, and six "no" votes.
NOTE: In the weeks following the BPAC meeting, apheresis device manufacturers Fenwal, Haemonetics and Terumo BCT — who previously had PF24RT24 products reviewed by the FDA — communicated with the agency and determined that it was appropriate to resubmit their applications with minor modifications based on the discussions at the BPAC meeting.
The agenda, meeting materials and transcript from the May 15-16 meeting are available. A search of the May 16 transcript will reveal brief presentations in the open public hearing by each of the sponsors of the four products discussed as PF24RT24: Sponsor A,Terumo BCT; Sponsor B, Fenwal, Inc.; Sponsor C, MacoPharma USA; and Sponsor D, Hemerus Medical. Of particular interest is the presentation by Michael Spearman, chief executive officer of Hemerus Medical, and John Hess, MD, director of transfusion medicine and the University of Maryland Medical Center, that also includes information on a new red cell storage solution that Hemerus has developed.