To the Commissioners, Deputy Commissioners, and Chief Scientists of the FDA:
Before I became a seminary student and full time pastor, I worked in the biotech industry for 13 years. I majored in biochemistry in college, and was in AP science classes in high school. During my career I mainly worked in pharmaceutical companies, both in laboratory and testing and creating regulatory documents. I even have my own paper copies of the CFR Part 21 (specifically parts 1-99 and parts 800-1299). Much of my career was spent testing blood specimens, beginning in the American Red Cross National Testing Laboratory (NTL) in Dedham, MA and ending at the Singulex Clinical Laboratory in Alameda, CA.
Suffice it to say, I know how blood testing works, the technology behind it, and how it’s regulated.
My years at the Red Cross NTL came after much activism throughout high school and college for AIDS and HIV education and awareness. What was really interesting about working at the NTL was that the training was very thorough. The NTL was under a consent decree to change its policies and procedures to operate more in line with the pharmaceutical/biotech industry. That training familiarized me with how the FDA regulates blood products and charted the course for the rest of my biopharma career
At the NTL I was hired primarily to do blood testing. I worked in viral testing lab that tested for HIV 1/2, HBV, HCV, and HTLV 1/2. The procedure for handling any positives, and possible false positives, was so strict that, in my opinion, it would have been highly unlikely that contaminated blood would enter the blood supply.
What I thought then, and what I still think now, is that the ban on gay and bisexual men, or anyone who has had sexual relations with gay or bisexual men, who have slept with other men, is not only discriminatory, but completely unnecessary.
While it has been a long time since my Red Cross days and my own personal lab skills are rusty, I know that blood testing technology has moved forward in leaps and bounds. It is now possible to test for HIV and other contaminants in the blood supply much more accurately and earlier in the infection cycle.
But this accuracy in testing was true even 13 years ago, and yet this discriminatory policy has stayed in place.
While I applaud the changing of the rule that was announced earlier today (December 23), I argue that any type of ban that is based the sexual orientation of the donor is still completely unnecessary. Since the FDA screens all donors for unsafe sexual practices already, singling out a particular sexual orientation is redundant. The sexual acts that gay and bisexual men do are also done by heterosexuals, and yet heterosexuals are still allowed to donate at will. Even the year long ban eliminates potential new donors based on fear and ignorance over the science that is tested and proven perpetuating the stigma that gay and bisexual men are somehow permanently tainted.
Denying more donors to an already short blood supply made no sense in 1998, and still does not make sense in 2014. It’s time that this policy was eliminated once and for all.
Rev. Gina A. Pond