HIV/MSM Docket Reopened

The authors of this piece participated in an evening long meeting last week to discuss the most appropriate responses to Food and Drug Administration's (FDA) reopening of its docket on the HIV guidance. The meeting was attended by ABC, Center for Biologics Evaluation and Research (CBER), leadership from FDA, American Medical Association (AMA), HIV clinicians and prominent advocates on behalf of men having sex with men (MSM), all of whom recognized the stigma attached to the continued time-based MSM deferral. The single issue was how (not whether) to move forward on policy adjustments in response to the long controversy around this the deferral. The current one-year deferral is based on sexual identity, as opposed to specific behaviors associated with increased risks for HIV infection. Individual risk assessments are being used elsewhere, but the personnel and environments are completely different than ours.  

Everyone recognized two things. First, new policy must not be seen to measurably increase risk from its current level. Second, with current testing, the vast majority of residual risk is from infection in the ≈10-day NAT-negative window period, so isolating the relevant recent behaviors and devising strategies to elicit them in the environment of U.S. donor rooms is the research agenda. (We did not discuss the growing concern of the impact of receipt of antiretroviral therapy on these issues, though this would have to be considered). Most of the non-blood bank participants knew only a little about operational imperatives or competing priorities, so we explained them, and FDA was clear that any changes will require an evidence base that does not yet exist. I think everyone came away with a reasonable sense that new policies are likely some years away. 

Good investigators are already planning the studies needed to identify, compose and validate the right questions for donors to elicit the relevant behaviors. The Transfusion-Transmitted Infections Monitoring System (TTIMS) is up and running to provide surveillance data.  

So, in the spirit of moving forward, what do we need to address? 

  1. How will our donors react to questions that are likely to be even more personal about sexual behavior than we have now? This needs to be included in any studies performed. 
  2. Who are the appropriate stakeholders to represent clinicians, blood recipients, and the bioethics community in this discussion?
  3. Who else should we hear from?

Let us know what you think. We need to consider comments to the newly opened docket and plan more complete discussions via webinar or at our meetings as needed.  

Louis Katz, MD; Chief Medical Officer

Debra Kessler, RN, MS; Director, Special Donor Services; New York Blood Center

Posted: 10/07/2016 | By: Louis Katz, MD; Chief Medical Officer & Debra Kessler, RN, MS; Director, Special Donor Services; New York Blood Center | Permalink
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