Experts Call for Easier Access to Emergency Contraception
Often this is not feasible during the narrow window of opportunity for which emergency contraceptives are most effective, which is soon after unprotected sex, according to Westhoff. "Access is a problem," she says.
Currently, Westhoff skirts the access issue by giving every new patient an undated, advanced prescription for emergency contraceptive pills. "If we had this product available over the counter, women could go to the drug store and get what they need," she says.
Although she was skeptical when she first heard of these products going over the counter, Westhoff says that it is safe because there are no ill effects from taking the pills and they cannot be abused.
Roderick McKenzie, chairman of Gynetics, Inc., the company that launched Preven, says "going over the counter is ultimately necessary to give access to a level that will make significant inroads unto the abysmal rate of unintended pregnancies and the abysmal rate of abortion."
But the road is littered with obstacles, he says. "We continue to think about petitioning the FDA, but it can take two to three years and cost up to $6 million," says McKenzie, whose company plans to introduce a progestin-only emergency contraceptive by 2001.
Contraception guru James Trussel, PhD, a professor of economics and public affairs and a faculty associate at the Office of Population Research at Princeton University in New Jersey, says both companies that make emergency contraception have expressed an intent to seek over-the-counter approval, and yes, it can be a long and costly process.
For instance, Trussel says, to qualify for over-the counter status, companies first have to demonstrate that emergency contraception is just as safe and effective without a prescription as it is with a prescription. The company must prove that a medication is not addictive, that there is no dose variance depending on patient size or shape and that the condition being treated does not need to be diagnosed by a doctor.
Ideally, these conditions shouldn't be much of a problem. "None of these conditions apply to emergency contraception," Trussel says.
The companies will also need to conduct a label comprehension study to show that women across the board can understand the labeling on the package, he says.
There is also the hurdle of opposition. As it stands, there are two groups of people who are opposed to emergency contraception pills going over the counter, Trussel says: those who are opposed to emergency contraception in general, which includes some of the people who are opposed to abortion, and groups that oppose widespread availability of emergency contraceptives on the grounds that women will abandon their regular contraceptive method in favor of emergency contraception.