Judge: Make Morning-After Pill Available to All Females
FRIDAY, April 5 -- A federal judge has ordered the United States Food and Drug Administration to make the so-called "morning-after pill" - an emergency contraceptive - available to all women regardless of age.
The judge from the Eastern District of New York gave the FDA 30 days to remove age restrictions on the sale of emergency contraception, such as Plan B One-Step. Currently, girls 16 and younger need a doctor's prescription to get the pill.
The judge's decision, released Friday, is the latest step in a 10-year, controversial debate about who should have access to the drug and why.
Plan B prevents implantation of a fertilized egg in a woman's uterus through use of levonorgestrel, a synthetic form of the hormone progesterone used for decades in birth control pills. Plan B contains 1.5 milligrams of levonorgestrel, more than "the Pill" contains. It is considered a form of birth control, not abortion.
Women's health advocates praised the decision by Judge Edward Korman in Brooklyn.
"Lifting the age restrictions on over-the-counter emergency contraception is a significant and long-overdue step forward for women's health that will benefit women of all ages," Eric Blankenbaker, a spokesman for Planned Parenthood Federation of America, said in a statement Friday.
"When a woman fears she might become pregnant after her contraceptive has failed or she has had unprotected sex, she needs fast access to emergency contraception, not delays at the pharmacy counter," he said.
Planned Parenthood called the ruling "good policy, good science, and good sense."
The National Latina Institute for Reproductive Health also came out in favor of the court ruling, noting it will benefit Hispanic and other immigrant women.
"For Latinas in particular, expanded access to emergency contraception is critical for making the best decisions for our families and ourselves. For too long, this important backup birth control method has been kept behind the counter and out of reach," institute spokeswoman Erin White said in a statement.
Minority women in the United States often face significant barriers to health care and suffer from the highest rates of unintended pregnancies, White said.
But not everyone was pleased with Korman's ruling.
"This is a political decision, made by those who stand to profit financially from an action that puts ideology ahead of the nation's girls and young women," said Janice Shaw Crouse, director and senior fellow at the Beverly LaHaye Institute, the think tank for the conservative women's group Concerned Women for America.
"It is irresponsible to advocate over-the-counter use of these high-potency drugs, which would make them available to anyone -- including those predators who exploit young girls," Shaw Crouse said.
In his ruling, Korman was dismissive of the government's arguments and, in particular, previous decisions by U.S. Health and Human Services Secretary Kathleen Sebelius that required girls under 17 to get a prescription for the emergency contraceptive. Korman wrote that Sebelius' actions "with respect to Plan B One-Step . . . were arbitrary, capricious, and unreasonable."
In 2011, Sebelius overruled a recommendation by the FDA to make the drug available to all women without a prescription. The FDA said at the time that it had well-supported scientific evidence that Plan B One-Step is a safe and effective way to prevent unintended pregnancy.
Sebelius, however, said she was concerned that very young girls couldn't properly understand how to use the drug without assistance from an adult.
She invoked her authority under the federal Food, Drug, and Cosmetic Act and directed FDA Commissioner Margaret Hamburg to issue "a complete response letter." As a result, "the supplement for nonprescription use in females under the age of 17 is not approved," Hamburg wrote at the time.
The Mayo Clinic has more about emergency contraception.
Posted: April 2013