FDA Questions Sex Selection for "Family Balancing"
The Virginia-based fertility clinic that holds an exclusive license to a sperm-sorting sex selection technique has announced that the Food and Drug Administration (FDA) will no longer allow its use for "family balancing" - that is, to bring "the number of children of each gender [sic] in a family closer to equal" because that's what the parents want.
In an email last week, the Genetics & IVF Institute (GIVF) wrote that the FDA has notified it that "[a]t this time, MicroSort® cannot enroll new participants in the clinical trial for the family balancing indication." GIVF's positive spin was that the FDA is allowing it to continue offering MicroSort "for genetic disease prevention for families who have an increased risk of a sex-linked or sex-limited disease," at least for the next six months.
In fact, beginning in 2008 the FDA repeatedly granted GIVF six-month "continued access" approvals to provide MicroSort both for "genetic disease prevention" and for "family balancing." The FDA's fifth and final six-month extension, which excluded "family balancing," was granted at some point last year. It's not clear why GIVF is making this announcement now; it's possible that the FDA has required them to communicate the restriction more clearly.
If the FDA decides to restrict the use of pre-pregnancy sex selection for family balancing, it would be a significant shift. For years, the agency has allowed GIVF to offer MicroSort under the auspices of a clinical trial, pending what it calls "pre-market approval." And notwithstanding the provisional nature of that status, the FDA has apparently not objected to GIVF's ads for MicroSort in high-profile publications or to its classic marketing come-ons.
For a year or so beginning in 2003, GIVF ran a series of ads in the Sunday Styles section of The New York Times and in several other publications with the boldface headline, "Do You Want To Choose the Gender Of Your Next Baby?" If so, the pitch continued, you can join "prospective parents...from all over the world" for an "exclusive scientifically-based sperm sorting gender selection procedure." On its website, GIVF advertised "FREE MicroSort for qualifying patients" who sign up for either its "Donor Egg" or "Preimplantation Genetic Diagnosis" program.
The New York Times ads prompted me to write about MicroSort and the sex selection controversies it raised (1, 2). In 2009, a letter written by Generations Ahead and signed by some 20 organizations including CGS asked the agency to hold a public advisory committee meeting before granting final pre-market approval for MicroSort. There's been no response to that request, but the GIVF announcement suggests that maybe - just maybe - someone is listening.
Previously on Biopolitical Times: