FDA Decision on EC Was Political
New Report Confirms Planned Parenthood's Worst Fears: FDA Decision on Emergency Contraception Was Political and Unusual;
Planned Parenthood Urges FDA to Protect Public Health and Expand Access
WASHINGTON, DC — The Government Accountability Office (GAO) today released its report on the Food and Drug Administration (FDA) 2004 decision to reject an application to give women over-the-counter (OTC) access to Plan B emergency contraception (EC). The report found the process by which the decision was reached unusual, with top agency officials being directly involved, and the decision possibly made months before it was formally announced. In response to the GAO report, Planned Parenthood Federation of America (PPFA) Interim President Karen Pearl issued the following statement:
"Every day the FDA delays the decision to increase access to emergency contraception, more women are needlessly put at risk of unintended pregnancy. The GAO report confirms the FDA has been playing politics with women's health all along, and the FDA has taken calculated steps to indefinitely postpone a decision about this safe, effective form of backup birth control. Now that the GAO has raised the curtain on these shameful tactics, it is time for the FDA to quit stalling and live up to its mission of protecting the public's health and well being.
"The report makes clear just how differently the EC application was handled compared to applications for other drugs. From 1994 to 2004, EC was the only drug whose over-the-counter application was denied, notwithstanding the overwhelming recommendation for approval by the FDA's own advisory committees. The directors of the offices that reviewed the Plan B application disagreed so strongly with the final decision that they refused to sign the not-approvable decision letter. The director of the Office of New Drugs also disagreed and also would not sign the letter. Among all decision letters regarding over-the-counter applications, the Plan B decision letter was the only one not signed by the FDA officials who would normally do so.
"As America's largest provider of EC, Planned Parenthood knows the importance of this medication, which can help prevent pregnancy after unprotected sex, including contraceptive failure or sexual assault. EC has been proven safe and effective, and the FDA's own advisory panels overwhelmingly approved over-the-counter status for Plan B. We urge the FDA to follow the science and immediately expand access to emergency contraception."
Experts estimate that wider access to EC could prevent up to 1.7 million unintended pregnancies a year — and 800,000 abortions.
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. 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.
On May 6, 2004, the FDA notified Barr Laboratories, which manufactures Plan B, that its application for over-the-counter status was not approvable at that time, citing concerns about adolescent use. Barr Laboratories submitted a revised application to the FDA, asking that emergency contraception be made available without a prescription to women 16 and older.
On August 26, 2005, the FDA announced it had completed its review of the application, the scientific data showed Plan B was safe to use as an OTC product for women 17 and older, but that it was delaying its decision yet again, this time to seek public comment on issues related to the approval of a product with OTC status for patients 17 and older and prescription status for patients 16 and under. The FDA did not commit to any timetable for initiating or concluding the rulemaking proceeding. The public comment period ended on November 1, 2005.
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.
November 14, 2005
May 12, 2014