FDA Delay On EC
Public Health Ignored; Ideology Trumps Science — Emergency Contraception Is Safe, Effective and Meets All FDA Criteria For Over- the-Counter Status
WASHINGTON, DC — Planned Parenthood Federation of America (PPFA) denounced today's announcement by the U.S. Food and Drug Administration (FDA) of yet another delay on issuing a decision on the application to make Plan B emergency contraception (EC) available over the counter.
"It is a terrible day for women's health and safety. It is crystal clear that the FDA has chosen politics over legitimate science," said PPFA Interim President Karen Pearl. "We are outraged that the FDA has yet again delayed a decision on making emergency contraception available without prescription. The FDA has failed its public health responsibilities and has failed women."
PPFA will launch an online advertisement campaign to ensure women know EC remains available by prescription and can be obtained at all Planned Parenthood health centers and from other health care providers.
Experts estimate that wider access to EC could prevent up to 1.7 million unintended pregnancies a year — and 800,000 abortions. In 1995, when Planned Parenthood launched its EC awareness campaign, Planned Parenthood affiliates distributed 17,270 EC kits. In 2003, that number had risen to 774,482 — an increase of 4,484 percent in eight years.
On December 16, 2003, a joint hearing of the FDA Nonprescription Drugs and Reproductive Health Drugs Advisory Committees voted 23 to four to recommend that the FDA make Plan B emergency contraception available over the counter for all women regardless of age. Most major medical and health care organizations, including the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics and the Society for Adolescent Medicine support making emergency contraception available without a prescription.
Emergency contraception pills contain hormones that reduce the risk of pregnancy when started within 120 hours of unprotected intercourse. The sooner emergency contraception is administered after unprotected intercourse, the better it works, making timely access critically important. Studies show that women do not rely on emergency contraception as a regular method of birth control.