Going Over the Counter? Legislators to Debate Future of the Pill
WebMD News Archive
The supporters have medical support for wanting to change the status of the
pill to over the counter. When initially approved in 1960, the pill was linked
to an increased chance of heart attack, stroke, and blood clots. But in the
1970s, the FDA approved several new versions containing much lower doses of
hormones, decreasing the likelihood of any of these side effects. But the
controversy over the new generation of birth control pills is still a focus of
concern. For example, a study coming out tomorrow in a major medical journal
will further report on the association between the pill and blood clots in the
However, there are significant social advantages to offering the pill over
the counter, Hatcher tells WebMD. For example, the costs would go down for a
large number of women, eliminating perhaps one of the "greatest barriers to
women obtaining contraceptives," he says. But the cost may actually go up
for women whose insurance used to foot some of the bill, because insurance
companies typically do not pay for over-the-counter drugs.
Moreover, women would be able to obtain the pill on a Sunday, when many
women are scheduled to take their first pill in a 21-day regimen that includes
one week off, Hatcher says. "It is one of the most important pills not to
miss," he adds, while noting that in combination, these changes also could
make the pill far more effective. The greatest barrier to its effectiveness is
compliance, he tells WebMD.
Perhaps the greatest advantage of an over-the-counter oral contraceptive,
according to both Grimes and Hatcher, is that the conversion of the pill to
over-the-counter status would make it available for emergency
"The pill should have done that a long time ago," Grimes tells
WebMD. The pill can help prevent pregnancy after unprotected intercourse by
taking large doses.
But the lack of a sponsor may keep the FDA from ever making a final decision
on this matter. In order for the FDA to make a decision of whether or not the
pill should be available without a prescription, an organization, such as a
drug company, must ask the FDA to do so. The problem is that the manufacturers
of the pill have yet to take a position on the matter.
"We don't have a policy with regards to the pill," Mark Munso, a
spokesman for drug manufacturer Ortho-McNeil, tells WebMD, in an answer that is
reminiscent of other pill makers' present stance.
There also may be lack of support from the medical community and an outcry
from doctors is very possible. A number of physicians rely on the required
office visits to offer regular preventive health care to women such as Pap
smears and breast exams, and they legitimately could argue that the visits are