For now, FDA rejects counter sales for ‘morning-after’ pill
Posted on May 7, 2004 | by Tom Strode
WASHINGTON (BP)--A federal government agency has refused to approve over-the-counter sale of a “morning-after” pill but has left open the possibility it might do so in the future.
The Food and Drug Administration confirmed May 7 it had sent a “not approvable” letter to Barr Pharmaceuticals, which had sought permission to sell the Plan B “emergency contraceptive” without a prescription. The FDA cited the lack of information on the pill’s effect on girls 16 years of age and younger in rejecting the application.
Pro-life and pro-family advocates, who contend “emergency contraceptives” can cause abortions and increase sexually transmitted diseases among young people, applauded the decision.
“This is a tremendous victory for women,” said Richard Land, president of the Southern Baptist Ethics & Religious Liberty Commission. “The dispensing of such a serious prescription drug over the counter would have caused significant health crises in the lives of thousands of women. All Americans should rejoice that their government has decided to do what government should always do -– put the best interests of its citizens first.”
Sen. Sam Brownback, R.-Kan., called the FDA’s action “common sense.”
“The morning-after pill is an overdose of birth control,” Brownback said in a written statement. “It makes no sense to offer a drug over the counter that is 50 times stronger than a drug that currently requires annual consults with doctors.”
Wendy Wright, senior policy director of Concerned Women for America, praised the FDA’s caution “about making a potent drug that can harm women available next to candy bars and toothpaste.”
“The morning-after pill is a pedophile’s best friend,” Wright said in a written release. “Morning-after pill proponents treat women like sex machines. Risking her health or life is a price they’re willing to pay to make sure she doesn’t breed.”
Abortion-rights advocates condemned the action. A spokeswoman for the Planned Parenthood Federation of America called it “anti-choice politics at its worst.”
“The FDA’s decision proves only one thing: Dangerous anti-choice ideology is trumping scientific fact at the expense of women’s health and well-being,” said Vanessa Cullins, PPFA’s vice president for medical affairs, in a written statement. “This is the latest assault in this administration’s war on choice.”
Plan B now can be purchased with a prescription, but supporters of over-the-counter sales argue the method’s value is limited by the need to obtain it quickly when sexual intercourse has occurred without the use of another form of contraception. Plan B is recommended for use in the first 72 hours after sex, but it is even more effective in the first 24 hours.
The pill works by restricting ovulation in a woman, and supporters argue it will prevent unplanned pregnancies and abortions. Opponents, however, say the method also can work after conception, blocking implantation of a tiny embryo in the uterine wall. In such a case, an abortion occurs, pro-lifers point out. The medical establishment largely disagrees that blocking implantation constitutes an abortion.
The American College of Obstetricians and Gynecologists, which supports over-the-counter sale of Plan B, says pregnancy does not begin until the fertilized ovum is implanted in the uterine wall. To pro-lifers, and those who abide by the traditional understanding, pregnancy begins with the union of a sperm and an egg -– known as fertilization or conception.
“Emergency contraception” is basically a heavier dose of birth control pills. In the “morning-after” regimen, a woman takes two pills within 72 hours and another dose 12 hours later. In addition to Plan B, the FDA also has approved prescription use of another “emergency contraceptive,” Preven. The FDA approved Preven before Plan B in 1998.
It appears opponents of “emergency contraceptives” will face a challenge in convincing the FDA to continue rejection of Barr’s request for over-the-counter status for Plan B.
In its letter to Barr, the FDA said the application for over-the-counter use contained no data on Plan B’s impact on girls under 14. Of the 585 subjects in a study of Plan B, only 29 were 14 to 16 years old, the FDA pointed out.
The FDA told Barr it could seek approval by providing evidence the pill is safe for girls under 16. It also could provide data for alternative use of Plan B as a prescription drug for girls under 16 and as a nonprescription drug for women 16 and older, the FDA said.
Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said in a written release he would “be working toward the expeditious evaluation of Barr’s response to the not approvable letter. If Plan B is approved for nonprescription use, it would dramatically increase access to this product and will represent an important incremental step forward in contraceptive availability in the United States.”
Barr Chairman and Chief Executive Officer Bruce Downey said May 6 in a written statement “we are encouraged by FDA’s suggestions, and look forward to working with the agency toward approval of Plan B for over-the-counter use.” He expects a new presentation to the FDA will take “months rather than years,” Downey told The Washington Post.
In rejecting Barr’s application, the FDA differed with its Nonprescription Drugs and Reproductive Health Drugs advisory committees, which voted 23-4 Dec. 16 for approval of Plan B’s over-the-counter sale.
In January, 49 members of Congress called on President Bush and then-FDA Commissioner Mark McClellan to deny the committees’ recommendation.
In February, the FDA delayed a decision on the Plan B application.
Barr Pharmaceuticals is based in New Jersey.