First emergency contraceptive product hits U.S. market shelves
Preven Emergency Contraceptive Kit is here, progestin-only pills coming
After almost 25 years of waiting, American women finally have a product approved by the federal Food and Drug Administra tion (FDA) for emergency contraception: the Preven Emergency Contraceptive Kit. With the doors now open for the contraceptive method, women may see two more progestin-only products enter the U.S. market in 1999.
Gynétics of Somerville, NJ, the company responsible for introducing Preven, has announced it is in advanced stages of developing a levonorgestrel-only emergency contraceptive. "We are hopeful that this [product] will be on the market before the end of 1999," states Roderick Mackenzie, company chairman and founder.
Another company, Women’s Capital Corp., based in Seattle and Washington, DC, plans to submit its New Drug Application to the FDA for a similar progestin-only product by the end of October, confirms Sharon Camp, PhD, company president. Company officials hope it, too, will receive FDA approval in 1999.
Competition in the emergency contraception marketplace can only bode well for women, notes Camp, who served as head of the Welcome, MD-based International Consortium for Emergency Contraception, a global initiative promoting the method.
"We have 100 brands of oral contraceptives [OCs] on the world market, so why should there only be one emergency contraceptive?" Camp asks. "The more companies that are out there advertising emergency contraception directly to the consumer and educating health care providers, the more likely it is that emergency contraception will become a standard part of reproductive health care." (See p. 143 for more details on Women’s Capital Corp. and the research supporting its product.)
The debut of the Preven Emergency Contra ceptive Kit signals a new market in women’s health care, notes Anita Nelson, MD, associate professor of OB/GYN at the University of California at Los Angeles and medical director of the Women’s Health Care Programs at Harbor-University of California at Los Angeles Medical Center in Torrance.
"We know with all these unintended pregnancies that women are having unprotected intercourse, and that their methods are failing them," Nelson observes. "If we have a product that women can ask for and that physicians can prescribe, we will be creating something that hasn’t been there before — we won’t be subtracting from something that exists now."
All systems were go as of Contraceptive Tech -nol ogy Update press time to have Preven in all Planned Parenthood Federation of America clinics and on the shelves of retail pharmacies. The kits also is being made available to family planning clinics and college student health centers, with information broadcast through the mail, Mackenzie says. (For more on Preven, check the World Wide Web site or dial the toll-free information number; both are listed in the resource box, p. 143.)
Preven is now available by prescription only, but that may change as Gynétics continues to track its usage, says Mackenzie. The company will cooperate with the FDA in evaluating whether over-the-counter (OTC) status is warranted, he says.
Most HMOs to cover
In looking at the OTC issue, Gynétics’ market research indicates that women want the opportunity to have emergency contraception reimbursed by their health care plans or by Medicaid, he adds. Preven carries Health Care Financing Administra tion approval for Medicaid reimbursement, and most health maintenance organizations have agreed to cover its costs, he says.
Preven should qualify under new legislation that will require federal employees’ medical insurance to cover contraceptives approved by the FDA, says James Trussell, PhD, associate dean of the Woodrow Wilson School of Public and Interna tional Affairs and professor of economics and public affairs at Princeton (NJ) University. Private companies that now cover contraceptives also will include Preven, says Mackenzie.
The approval of the new emergency contraceptive may indeed represent the turning point in gaining insurance coverage for all contraceptives, predicts Arthur Caplan, PhD, director for the Center for Bioethics at the University of Pennsy lvania in Pittsburgh. Women are going to demand emergency contraception, with providers joining in the chorus, Caplan observes. The result is a constituency that will bring pressure to obtain coverage for emergency contraception, he says.
A big advantage of Preven is its cost. Women will be able to fill prescriptions at a pharmacy for about $20, says Mackenzie. That’s less than any OCs currently used as emergency contraceptives, says Robert Hatcher, MD, MPH, professor of OB/GYN at Emory University in Atlanta and chairman of the CTU editorial advisory board.
Women previously have had to buy an entire month’s supply of OCs if they filled their emergency contraceptive prescriptions at a retail facility. By buying the kit, women will be purchasing exactly what they need for pregnancy prevention.
The Preven kit consists of an easy-to-use pregnancy test, a patient information guide, and four blue pills. Each pill contains 0.05 mg ethinyl estradiol and 0.25 mg levonorgestrel. After a woman determines she is not pregnant by using the test, she takes the first two pills as soon as possible within 72 hours after unprotected sex and the last two pills 12 hours later.
"Having the kit makes this whole process much simpler," notes Mackenzie. "It is simpler for the doctors to prescribe, it is simpler for the pharmacists to dispense, the instructions make it simple for a woman to use, the pregnancy test adds confidence, and just the right number of the right pills are there — there’s no guessing."
The pregnancy test offers peace of mind because woman know the pills will work for them if they are not already pregnant, says Nelson. Women are encouraged to seek provider care if the test proves positive.
Meeting women’s needs
It is estimated that emergency contraceptive pills could prevent half of all abortions and unintended pregnancies that occur each year in the United States, notes Judith DeSarno, president and chief executive officer of the Washington, DC-based National Family Planning and Reproductive Health Association. With more than 11 million women now using contraceptive methods associated with high failure rates, Preven and similar products have a large market opportunity.
Prior to its Sept. 2 announcement, the FDA had declared 10 brands of regular OCs safe and effective for use for emergency contraception, notes Trussell. However, the labeling on these products fails to include any specific instructions for postcoital use.
"Not having a dedicated product specifically packaged and labeled for emergency contraception has been the largest single barrier to more widespread use," Trussell says. With Preven in hand, a specific product can be marketed and promoted actively, with clear package instructions available for guidance, he notes.
"For a long while, we have been saying that half of the 3 million unintended pregnancies each year in the United States could be prevented if emergency contraceptives were widely available and consistently used," Hatcher agrees. "The exciting thing about Preven is that it is going to help us in a major way toward achieving that goal."
For more information on Preven, contact:
• Gynétics, P.O. Box 8509, Somerville, NJ 08876. Tele phone: (908) 359-2429. Fax: (908) 359-6660. A special provider and consumer toll-free number is available for Preven: (888) Preven2. World Wide Web: http://www.Preven.com.
For more on emergency contraception, contact:
• Emergency Contraceptive Hotline, 21 Prospect Ave., Princeton, NJ 08544-2091. Telephone: (888) NOT-2-LATE. E-mail: email@example.com. World Wide Web: http://opr.princeton.edu/ec/.