FDA approves nonprescription sales of Plan B pills for women 18 and older

Females 17 and younger will need a doctor's prescription for the pills.
PHILADELPHIA INQUIRER
PHILADELPHIA -- The Food and Drug Administration approved nonprescription sales of emergency contraception to women 18 and older Thursday, capping a long, tortuous saga about drug regulation, public health, politics and morality.
Especially politics and morality.
Over-the-counter Plan B will be available only in pharmacies, only from pharmacists, only to women with proof of age -- and probably not before the end of the year because Barr Pharmaceuticals Inc. must update the labeling of Plan B. Females 17 and under still will need a doctor's script to buy the $25 product.
Reaction was swift and predictably polarized.
Women's health advocates and medical organizations had endorsed Barr's original 2003 application for over-the-counter sales without an age restriction. Thursday they applauded the FDA's ruling, but said it was long overdue, unnecessarily restrictive and shaped by political pressure.
"For nearly three years, politics took precedence over good science and good health policy decisions, and women's health suffered," said George Washington University professor Susan Wood. A year ago, she quit her job as the FDA's assistant commissioner for women's health to protest Plan B's bureaucratic limbo.
Conservative political and religious groups decried the FDA's decision, contending that easier access to emergency contraception will increase promiscuity and sexually-transmitted diseases and give rapists a way to eliminate evidence of their abuse.
Opposition
Some anti-abortion groups also denounced Plan B as an abortion pill, even though it has no effect on an established pregnancy. It works by preventing ovulation, fertilization or implantation.
"It is no secret that Plan B is a deadly drug that . . . can act to take the life of newly conceived babies in the days immediately following fertilization," said Judie Brown, president of American Life League. "The FDA should not have authorized any use of this risky drug regimen ... and it certainly should not have made it readily available over the counter."
Plan B is a high dose of levonorgestrel, a hormone in ordinary birth control pills. As long ago as 1976, research showed that taking multiple birth control tablets at once could be used for pregnancy prevention after sex.
The method works if the pills are taken within five days of unprotected sex -- but the sooner after sex, the more effective. That's a big reason advocates wanted to simplify women's access to Plan B.
The FDA has spent more than three years in oft-headlined turmoil over Plan B. While top officials claimed over-the-counter sales posed "novel" and "complex" problems, FDA's scientific staff and advisors concluded such sales would be safe and prudent.