WASHINGTON, June 30 /PRNewswire/ -- Representatives of several national
women's health research and advocacy organizations testified before the Food
and Drug Administration today in support of making emergency contraceptive
pills available over-the-counter.
Emergency contraceptive pills are a higher dose of birth control pills
that, if taken within 72 hours of intercourse reduce the chance of pregnancy
by 75 percent or more. (Emergency contraception is not an abortifacient and
is not to be confused with mifepristone or RU-486).
Recent data from the World Health Organization shows that the efficacy of
ECPs is significantly greater the sooner the pills are taken. Tara Shochet of
the American Society for Emergency Contraception warns, "Every hour lost
tracking down a doctor and waiting for a prescription boosts a woman's risk of
unwanted pregnancy." This "'need for speed' is the most compelling reason why
ECPs should be sold over-the-counter," according to Dr. Elizabeth Raymond of
Family Health International.
Nearly 50 percent of all pregnancies in the U.S. are unintended and over
half of those pregnancies end in abortion. An estimated one half of these
abortions could be prevented annually through wider use of emergency
contraceptive pills. "Increasing access to emergency contraceptive pills
(ECPs) is the single most promising avenue for reducing unintended pregnancy
and the need for abortion," says Elizabeth Cavendish of the National Abortion
Rights Action League.
Women's health advocates were unanimous in their testimony that ECPs meet
the FDA's standards for over-the-counter distribution. ECPs are proven to be
safe and effective. Furthermore, a doctor or health care provider is not
necessary to diagnose or recommend treatment of ECPs.
"Requiring a prescription for emergency contraceptive pills is medically
unnecessary," says Dr. Raymond. Amy Allina, of the National Women's Health
Network agrees: "With proper labeling, women can safely take ECPs without the
supervision of a provider."
Several presenters pointed to the results of a recent survey of providers
listed on the Emergency Contraception Hotline (888-NOT-2-LATE) as evidence
that keeping ECPs on prescription status acts as a barrier to access for many
women. "Even when women called clinicians during regular business hours, only
three out of every four attempts to obtain ECPs resulted in appointments or
telephone prescriptions within 72 hours," Cavendish reports. Even finding a
provider can sometimes be difficult. For example, only four providers are
listed on the Hotline for the entire state of South Dakota.
Kirsten Moore of the Reproductive Health Technologies Project points out
that OTC status would help to ensure that no woman is denied access to
emergency contraception because of so-called "conscience clauses." Conscience
clauses are policies that enable a health care provider to opt out of offering
a service to a patient on the grounds of his or her moral opposition.
Observes Moore, "making ECPs available OTC is the best way to guarantee that a
woman who is doing all she can to prevent an unwanted pregnancy is not denied
service by a doctor or pharmacist who believes what she is doing is
While it is widely believed that moving ECPs over-the-counter will
dramatically increase access, some advocates are concerned that an OTC product
will be too expensive for women on a low or fixed income. They are therefore
encouraging the FDA to take the unusual step of allowing the same or very
similar products to be available both by prescription -- and therefore
reimbursable under Medicaid -- and OTC. "No woman should be denied the means
to prevent an unwanted pregnancy," states Moore.
CONTACT: Kirsten Moore of the Reproductive Health Technologies Project,
SOURCE Reproductive Health Technologies Project