The primary obstacle to getting a new non-latex condom to market, then and now, is the need for clinical trials. Latex condoms dont have to be tested in human studies to get FDA approvalas long as a manufacturer can demonstrate that its new latex condom is substantially equivalent to an existing latex condom in terms of materials, length, width, and other physical specifications, that latex condom can be sold. But makers of new material condoms must demonstrate that their product performs comparably to latex when used by real, live sex partners.
Today, the protocol for a 1,000-use slippage and breakage studythe type of clinical condom trial required by the FDA for new condom designsis well established. At the California Family Health Council, which has conducted dozens of condom acceptability trials, researchers usually enroll between 200 and 400 monogamous, STI-free heterosexual couples who are using a backup form of birth control, like the pill or an IUD. Each couple receives three to five commercially available latex condoms, and three to five of the new condom being tested. The condoms are unlabeled, and participants dont know which condom theyre getting first (although when youre comparing two condoms that look differentlike latex and polyurethaneits obvious). The couples are instructed to use the condoms for vaginal intercourse and then individually write detailed reports about who put the condom on, which sexual positions they engaged in, how long the sex lasted, whether they used additional lubricant, whether they had an orgasm, andcruciallywhether the condom slipped off or broke during intercourse. The couples also attend detailed in-person interviews with researchers, and the man has to submit penis measurements. Each member of the couple usually receives $100 for his or her participation. All in all, a 1000-use condom performance study costs between $500,000 and $1 million.
But in the early 1990s, when McGlothlin and LIG wanted to test their polyurethane condom with humans, the FDA did not have guidelines in place. So the FDA improvised its regulation and labeling of the polyurethane condom, making a lot of mistakes along the way.
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In spite of their niche popularity and excellent clinical trial results, the FDA challenged the acceptability of TheyFit condoms in December 2006, apparently having noticedmore than five years after clearing the condoms for salethat some of the 55 sizes did not meet ASTM dimensional requirements. The smaller sizes, in particular, didnt hold the requisite volume of air and water in the air-burst test and the water-leak test, because they were, well, smaller. Sadlo, who confirms Glickmans account, was given 30 days to remove his condom from the market, and, after consulting with an attorney, complied. (The FDA is unable to comment on why a manufacturer discontinued marketing a device, the FDA spokesman told me when I tried to confirm Glickman and Sadlos story.)
Glickman was enormously frustrated by the experience. He had been trying for years to make money selling condoms, starting in the late-1980s, when, as a college student, he branded a batch of latex condoms with his school mascot, Jumbo the Elephant, and went from dorm room to dorm room selling them. For Glickman, TheyFit was an amazing opportunity to get people excited about using condoms. But the FDA didnt see it that way. They just saw their regulation, says Glickman. In his view, the FDA didnt know how to change the regulation; they didnt seem to care to want to change the regulation.
In 2011, the international equivalent of the ASTM, called the International Standards Organization, finally settled on testing methods for a broader range of sizes. That same year, TheyFit began selling an expanded range of 95 sizes in the European Union. But the ASTM has been slow to change. In December 2013, when the ASTM subcommittee voted on expanding the size range allowed in the standard, everyone was in favor except for FDA representatives, citing concerns that small condoms might not fit over the mandrels used to administer the air-burst test, according to an ASTM committee member.
