Internet opens access to contraceptive methods

Add contraception to the virtual shopping cart as Internet companies offer birth control methods for sale on the World Wide Web.

These companies give American women access to products that are not available on the U.S. market. Such items as levonorgestrel IUDs, contraceptive sponges, and electronic fertility monitors can be purchased from at least two sources on the Internet, an informal survey by Contraceptive Technology Update reveals.

While the products may not carry U.S. Food and Drug Administration (FDA) approval, the companies are within legal rights to sell women contraceptives under personal importation laws, contends Franklin Hilliard, owner of Babytech, a Kelowna, British Columbia-based firm.

FDA permits small amounts

For many years, the FDA has permitted individuals to bring into the country small quantities of drugs sold abroad but not U.S.-approved, providing that the drugs do not pose unreasonable or significant safety risks and are for personal use only. This same understanding has allowed individuals to import through the mail personal use quantities of unapproved drugs that might be helpful in treating their conditions.

Hilliard, a Web editor, began his company a year ago. Although he is not a health care provider, he says his company philosophy is that "women everywhere should have access to the latest advances in birth control and family planning technology."

Custer Tang, RPh, sees the Internet access through his Calgary, Alberta-based company, Global Drugs, as a natural extension of the mail order business he runs along with his licensed pharmacy. "We always like to help customers the best we can," he says. "We don't just want to sell them a product."

'Sponge-worthy' source

Most of the Internet orders from American women have been for the Protectaid contraceptive sponge, Hilliard and Tang report. Manufac tured by Axcan Pharma in Montreal, Canada, the sponge debuted on the Canadian market in February 1996. A polyurethane foam sponge, it contains low concentrations of three spermicides to provide contraceptive protection. Protectaid is sold as an over-the-counter product in Canada. Both Babytech and Global Drugs buy their sponges from a drug supply company, and not from the manufacturer.

American women have been looking for a nonhormonal method similar to the Today sponge ever since the product was removed from U.S. market shelves in 1995. (Whitehall-Robins Healthcare of New York City decided to pull the product on its own accord due to substandard manufacturing practices. See CTU, March 1995, pp. 43-44, for more information.)

"When the Today sponge came off the market in the United States, this left some 20 million American women who had been used to using the sponge high and dry," says Hilliard. "It was the famous Seinfeld episode [where a shortage of sponges prompts Elaine to determine whether a boyfriend is 'sponge-worthy']."

While almost all of Babytech's shipments of sponges have crossed into the United States with no problems, about 1% have been detained, reports Hilliard. The detainment has come when import officers question whether the sponges can be considered drugs, which pass under the personal importation regulations, or devices, which cannot, he notes. Tang says his company has had no problem in shipping any product, including condoms, sponges, gels, IUDs, and diaphragms.

"These esoteric matters don't really matter to the customers," Hilliard observes. "The customers are anxious to get them, we're happy to supply them, and that's basically been the basis of the business."

Babytech also offers the levonorgestrel IUD. Manufactured by the Finnish company Leiras Oy, now part of Berlin, Germany-based Schering AG, it is marketed in several European countries under the tradename Mirena. (For more information about the levonorgestrel IUD, see CTU, January 1997, pp. 4-6.)

"Our policy is that we require the purchaser to either be a gynecologist or a doctor, or to have a letter or some indication from their doctor, or to give us the doctor's address that we can ship it to, since this is something that can't be inserted by an individual," Hilliard says. "It has to be inserted by a medical practitioner. Our view is that the prospective customer needs to have discussed it with their doctor."

Legalities involved

What are the legal liabilities for the provider who performs an IUD insertion of a non-FDA-approved device? Legal liabilities are there just as they are for sanctioned products, points out Janet Benshoof, JD, president of the Center for Reproductive Law and Policy in New York City.

Whether or not the Internet would give long arm jurisdiction to the manufacturer remains to be seen, Benshoof says. Because the product is not manufactured or marketed in the United States, the manufacturer may have some defense, she observes. In addition, the Internet companies do not buy their products directly from the manufacturer, which may add a further level of defense.

"I think the manufacturer would have some kind of defense that it did not market it here, whereas the provider wouldn't have that defense," she says.