WASHINGTON, Jun 30 (Reuters Health) - During a public hearing convened by
the US Food and Drug Administration (FDA) on Thursday, several women's health
organizations urged the agency to switch emergency contraceptives from
prescription to over-the-counter (OTC) status, arguing that the drugs are safe
and will not be abused.
Emergency contraception consists of a combination of birth control pills,
one dose that must be taken within 72 hours of unprotected sex and the second
dose taken 12 hours later. While doctors can give women a combination of
standard oral contraceptives, there are two products on the market packaged
specifically as "morning-after pills." Those include Preven, which is a
combination of estrogen and progestin, and Plan B, which contains progestin
alone.
Such emergency contraceptives "should be available OTC," said Dr. Beverly
Winikoff of the Population Council. She noted that they have a low potential for
harm and that it's "impossible...to abort or damage a fetus if a woman takes
them when she's already pregnant."
Legal director of the National Abortion and Reproductive Rights Action
League (NARAL), Elizabeth A. Carendish had a similar perspective. "We would like
emergency contraceptives to be on the shelves, but if pharmacists can provide
them...that's still a big improvement," she said. The side effects of the drugs
are "less dangerous than either pregnancy or childbirth," Carendish commented.
She said that emergency contraceptives are most effective when taken within
the first 12 hours of unprotected sex so it's crucial that they are available
when a woman needs them. Making them available over-the-counter would help
facilitate such access, she said. Carendish noted that emergency contraceptives
"could reduce the number of unintended abortions and pregnancies by half
annually."
Family Health International representative Dr. Elizabeth Raymond also urged
the FDA to switch emergency contraceptives to OTC status.
The American Society for Emergency Contraceptives (ASEC) also favored making
the drug available OTC with no age restrictions on who can purchase the product.
Tara Shochet, deputy director of ASEC said that in Washington, where emergency
contraceptives have been available OTC through a pharmacist since 1998, there's
no evidence of abuse. A study in Scotland in which women received emergency
contraceptives ahead of time showed no evidence of abuse either, she pointed
out.
Shochet noted also that Britain is moving towards making emergency
contraceptives available from pharmacies.
"Emergency contraceptives could be $100 million product in the US with the
proper support and advertising," Dr. Jack E. Stover, chief operating and
financial officer of Gynetics, which manufacturers Preven, said.
"We believe a well-planned and controlled expansion of ECs to OTC...makes
good sense," he added. He suggested that if emergency contraceptives are not
available on the shelf, they should be available through the pharmacist with
proof of identification and age.
