Blood Products Advisory Committee
Food and Drug Administration
Silver Spring, Maryland
By Peter Sprigg
Senior Fellow for Policy Studies
Family Research Council
May 13, 2015
I want to thank the members of this committee for their conscientious work. It was my privilege to address you at your last meeting on December 2. After I did so, I was gratified to hear members of the committee express and expand upon some of the same concerns that I tried to articulate. For example, excerpts from the summary minutes of that meeting report:
- A concern was expressed that MSM might misunderstand a one year deferral as a ... message that MSM in general may safely donate blood.
- Some members commented that behavioral research is needed to better understand donor compliance with respect to a potential change in the deferral policy for MSM.
- Many members of the Committee commented that the decision for a policy change related to deferral of MSM as blood donors needed to be science-based.
- Certain members commented that an abundance of data to support a change in policy has not been demonstrated and that safety of a revised policy is uncertain.
- One member stated that the usual approach to blood safety is based on the precautionary principle and a change in deferral policies should not be made if there is a potential for increased risk to the blood recipient.
- Certain members commented that blood donation is not considered a civil right and many groups are excluded from blood donation because of various risk factors.
However, the most significant aspect of the meeting may have been what did not happen. This committee did not vote to recommend a change in the lifetime deferral as blood donors of men who have had sex with men (MSM). In fact, this committee did not even take a vote at all on that issue.
Nevertheless, only three weeks later, and only two days before Christmas, this agency, the FDA, announced that it would make a change to this longstanding policy that protects the public health. And now yesterday -- only one day before this meeting of the committee -- the FDA released its guidance document for implementing that change.
Even today, we have had the odd experience of hearing the FDA explicitly renounce any intention to seek "advice" on this topic from its own "advisory" committee. What this suggests to me is simple -- the fix is in. The decision had already been made to change the policy -- not for scientific or medical reasons, but for political ones, in order to appease the demands of a tiny, but very vocal, special interest group.
Such conduct is inexcusable for an agency charged with protecting the public health. The FDA should immediately put a halt to the proposed change in policy, and instead heed the concerns already expressed by members of this committee.