Women Clamor for Long-Delayed Return of the Sponge

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Still no sponge

(WOMENSENEWS)–Ever since Seinfeld’s Elaine determined that not all of her boyfriends were “Spongeworthy” of her shrinking supply of the suddenly extinct contraceptive, the sponge has garnered a cult-like following. But for its many anxious fans, tomorrow seems an unlikely return date for the Today sponge.

The sponge is one of the few over-the-counter, non-hormonal, woman-controlled contraceptives approved for use in the United States. But Whitehall-Robbins, the only U.S. manufacturer of the sponge, voluntarily discontinued it in 1994, citing its unwillingness to finance equipment upgrades mandated by the U.S. Food and Drug Administration.

In 1999, when Allendale Pharmaceuticals announced that it was bringing back the device, women across the country partied like it was, well, 1994. Internet chat boards lit up: “When? When? When?” cried one eager fan. Others simply expressed their joy: “My prayers are finally answered,” sighed another woman.

Three years later, women are still waiting.

“I have been concerned about its return for over two years now,” says 35-year old Lisa Raccuglia of Mahwah, N.J., who used the sponge for more than two years. “What exactly is the hold-up? It’s a product. It’s safer than a cigarette, which is in full distribution in this country.”

Red Tape Delays Sponge’s Re-Release

The Today Sponge, a doughnut-shaped cervical barrier, works to prevent pregnancy by releasing the spermicide nonoxynol-9 for a 24-hour period. It is 90 percent effective at preventing pregnancy, offering more protection than condoms but less than most birth control pills. Although it is not considered a reliable defense against sexually transmitted diseases, women say they like the sponge for a variety of reasons: It is sold over the counter, can be inserted as long as 24 hours before sex and, unlike condoms, it can be left in place for multiple rounds of intercourse.

The sponge was widely available in the United States for 12 years before its discontinuation and is legal in neighboring Canada–which does not regulate the contraceptive as a drug and where some American women now go on sponge-buying sprees.

When Allendale Pharmaceuticals first bought the rights to produce the sponge in 1999, company officials expected to have it back on the market that fall. Already approved by the Food and Drug Administration, the device seemed to need only some packaging changes and a factory inspection to be back on drugstore shelves.

Then government regulators requested significant packaging changes, including the addition of warnings about Toxic Shock Syndrome, and Allendale changed its anticipated re-release date to summer 2000. Then winter 2000. Two years later, the sponge’s return has been thwarted by continuous fixes, requests for changes at the company’s Pennsylvania manufacturing plant and stalls from the FDA, including two appointments the agency made–and then cancelled–to inspect the plant.

Gene Detroyer

“Today’s sponge is an approved product,” says Gene Detroyer, chief executive of Allendale Pharmaceuticals. But the FDA must re-approve a device if the location of its manufacture changes, and “the process is long and tedious,” Detroyer says, alleging that the agency has given Allendale a list of “fixes” without telling the company what it’s looking for.

FDA spokeswoman Susan Cruzan won’t comment on Detroyer’s claims, but she concedes, that two years is a long time for a previously approved device to be banned for sale. The sponge “has been proven safe and effective in clinical trials,” Cruzan says, adding that its re-release has been delayed “for reasons unrelated to efficacy and safety.”

Proponents Believe Ban on Sale is Based on Politics, Not Science

In a 2001 letter to Dr. Susan Wood, director of the FDA’s Office of Women’s Health, longtime sponge fan Caroline Stamps writes, “The red tape has gone on long enough. We, the women of America, are ready to make a choice. We are ready to take control over our reproductive decisions. We respectfully request that you give Allendale Pharmaceuticals the green light and allow production of one of the few birth-control methods that did not infiltrate our bodies with hormones or did not involve a long term commitment.”

But that light is still red. President Bush’s refusal to release congressionally authorized funding for international family-planning programs, as well as his proposed budget increases to domestic abstinence-only programs, has many sponge fans, women’s health advocates and reproductive-rights activists wondering if the FDA isn’t stalling for reasons unrelated to the sponge itself.

“It’s definitely gotten tougher with the current administration,” Detroyer says.

In March 2001, shortly after the Bush administration took office, regulators advised Detroyer that he could no longer give out samples of the sponge for educational purposes, to investors or to the media–even though the sample products were clearly marked according to government specifications.

Then, early this year, the FDA demanded that the company run three six-month stability studies instead of the 90-day stability study that officials had originally requested to determine the safety and stability of the device. A stability study tests to make sure a product remains in the same form for a certain period of time following manufacture.

Cruzan of the FDA declines to comment on the agency’s recent demands.

Detroyer was surprised. “Not only has the sponge been out on the market and available for years, but there has never been a major health risk or health problem from it,” he says. “What better proof that you have a safe and advantageous product than a quarter of a billion uses?”

“Friends of the Sponge” Lobbying for Governmental Approval

But hope is not all soaked up. More than 3,000 supporters have joined Detroyer’s “Friends of the Sponge” e-mail list, which encourages members to lobby the government to approve the device. His inbox is teeming with strongly worded letters from women demanding their right to make their own reproductive decisions.

And for someone who started as Allendale’s “marketing/sales guy,” Detroyer has become an advocate for women’s reproductive rights.

“It amazes me the lack of choices that women have in the United States compared to other places in the world,” he says. “I’m appalled that a country with this much education and resources can’t get enough contraceptive products for women.”

Naomi Mendelsohn is a writer living in San Francisco.

For more information:

Allendale Pharmaceuticals:
http://www.allendalepharm.com/

Today Sponge:
http://www.todaysponge.com/

Food and Drug Administration
Department of Women’s Health:
http://www.fda.gov/womens/default.htm


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