Manufacturer Discontinuing Contraceptive Sponge
NEW YORK (AP) _ The maker of the Today Sponge, once the most popular over-the-counter contraceptive for women, is discontinuing the product, saying it can’t meet stringent new government safety rules.
Whitehall-Robins Healthcare, which voluntarily suspended production of the sponges last year, said Tuesday that it would cost too much to upgrade its manufacturing plant to meet the rules. Whitehall is the only maker of contraceptive sponges in the world.
The Food and Drug Administration last year questioned the purity of water and air at the plant where the sponges are made. A spokesman said Tuesday that the agency was only following longstanding safety guidelines.
Birth control advocates bemoaned the loss of the sponge, saying it further restricts contraceptive choices that women can control.
Although the number of women who used the sponge was small compared to condoms or prescription products like the pill, it had an important niche, said Beth Frederick spokeswoman for Alan Guttmacher Institute, a reproductive health research organization in New York.
``For women who had problems with hormonal methods, or weren’t in a position to use a condom or had difficulty with an IUD or no physician, it had a lot of advantages,″ she said. ``It was over the counter and it was women-controlled and limiting choice is never a good thing.″
The decision is likely to have little impact on Whitehall, a division of the drug and food conglomerate American Home Products Corp. At its peak in 1993, the sponge garnered about $17 million in annual sales out of American Home’s $8 billion.
American Home has had trouble with two other contraceptives. Users of the Norplant hormone implants have complained that doctors haven’t been trained adequately on their removal. Before American Home bought A.H. Robins in 1989, Robins made the Dalkon Shield, which caused spontaneous abortions, infections and at least 18 deaths.
The sponge was introduced in 1983 and was made at a relatively old factory in Hammonton, N.J., where Whitehall also made products like Preparation H hemorrhoid products and Dristan nasal spray.
It was more popular than spermicides and suppositories because it could be inserted into the vagina up to 24 hours before sex. By 1993 it had about 29 percent of the $62 million market for female over-the-counter contraceptives.
However, its appeal was limited by a relatively high 8 percent failure rate, even with perfect use. Its market share of all female contraceptives _ including prescription products _ peaked at around 2 percent, Whitehall said.
In 1993, an FDA inspection turned up unacceptably high bacteria rates in air and water at the Hammonton plant.
The company voluntarily suspended sponge production since the product is more susceptible to contamination. However, it continued to insist the product was safe and none were recalled.
A recent review led the company to conclude that existing equipment is unusable and starting from scratch with a new plant isn’t worth it, Karen Brown, Whitehall-Robins spokeswoman, said.
``While the product has always met the specifications according to our interpretation, FDA has clearly been enhancing their requirements, subjecting products to more rigorous testing,″ she said.
Adding new equipment, training and perhaps reformulating the product could take two to five years, she said. ``By that time Today sponge users would probably have moved onto another contraceptive.″
FDA spokesman Don McLearn said Tuesday the agency’s safety standards haven’t changed significantly.