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FDA Approves Nonprescription Sales of Plan B
Susan Jones
Senior Editor
(CNSNews.com) - The Food and Drug Administration approved over-the-counter sales of the "morning-after pill" on Thursday, but only for girls over the age of 18.
The hormone pill, until now available only with a prescription, prevents implantation of a fertilized egg if it is taken within a few days of unprotected intercourse.
Easier access to the drug known as Plan B has drawn strong opposition from conservative groups, who say it will end up in the hands of young girls, regardless of what the rules say.
Focus on the Family is among the many groups that have argued against over-the-counter sales of Plan B, which it describes as "an invitation for adult men to pressure underage girls to have sex with the promise of an easily accessible magic pill to prevent or abort a pregnancy."
Pro-life groups believe that life begins at conception -- and that interfering with the growth of a fertilized egg is an early form of abortion.
President Bush infuriated pro-life activists when he appeared to waffle on the issue earlier this week. (See story)
In an announcement on its website Thursday morning, the FDA compared Plan B with birth control pills:
"Like other birth control pills, Plan B has been available to all women as a prescription drug," the FDA said. Plan B contains the same ingredient as birth control pills do, but Plan B has a higher dose and a different dosing regimen.
"When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under," the FDA said.
The FDA said Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a "rigorous labeling, packaging, education, distribution and monitoring program."
The Planned Parenthood Federation of America hailed the FDA's decision to make "emergency contraception" (EC) available to girls 18 and over -- but it expressed dismay at the "scientifically baseless restrictions" that deny younger girls access to "backup birth control."
"Today's announcement is an important victory and long overdue. Women need timely access to backup birth control -- last year alone, Planned Parenthood provided more than one million women with emergency contraception to prevent unintended pregnancy," said PPFA President Cecile Richards.
Richards said the United States has one of the highest rates of teen pregnancy in the western world -- so "anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy."
PPFA said its research shows that over-the-counter access to Plan B will not increase or encourage teen sexual activity; and it says studies show that women do not use Plan B as a regular method of birth control.
"Experts estimate that wide access to EC could prevent up to 1.5 million unintended pregnancies, and 800,000 abortions, a year," the PPFA website says.
The FDA said its decision to expand access to Plan B followed "an extensive process," including "expert advice" from a joint meeting of two FDA advisory committees and a public comment period.
The FDA also noted that the request to make Plan B over-the-counter for some women and prescription-only for others "raised novel issues."
Indeed, the Family Research Council has questioned whether the FDA has the legal authority to approve "dual status" marketing of the same dosage of a drug. The FRC also argued that the FDA lacks the authority to enforce an age restriction.
Focus on the Family believe the age restriction is worthless: "At best, it is unrealistic for the president and the FDA to believe teens won't have access to these pills and won't be at risk of exploitation; at worst, it is irresponsible for them to assume an age limit for the over-the-counter access is a safe and parent-respecting compromise."
President Bush on Tuesday surprised pro-life groups when he said, "I believe that Plan B...ought to require a prescription for minors, is what I believe." He also expressed support for the FDA's Acting Commissioner Andrew Von Eschenbach, who supports over-the-counter sales of pill.
Sens. Hillary Rodham Clinton and Patty Murray earlier placed a hold on Von Eschenbach's nomination as FDA commissioner, to speed up a ruling on Plan B.
See Earlier Story:
President Bush Inconsistent on Life Issue, Groups Say (22 Aug. 2006)
Subscribe to the free CNSNews.com daily E-Brief.
Send a Letter to the Editor about this article.
The hormone pill, until now available only with a prescription, prevents implantation of a fertilized egg if it is taken within a few days of unprotected intercourse.
Easier access to the drug known as Plan B has drawn strong opposition from conservative groups, who say it will end up in the hands of young girls, regardless of what the rules say.
Focus on the Family is among the many groups that have argued against over-the-counter sales of Plan B, which it describes as "an invitation for adult men to pressure underage girls to have sex with the promise of an easily accessible magic pill to prevent or abort a pregnancy."
Pro-life groups believe that life begins at conception -- and that interfering with the growth of a fertilized egg is an early form of abortion.
President Bush infuriated pro-life activists when he appeared to waffle on the issue earlier this week. (See story)
In an announcement on its website Thursday morning, the FDA compared Plan B with birth control pills:
"Like other birth control pills, Plan B has been available to all women as a prescription drug," the FDA said. Plan B contains the same ingredient as birth control pills do, but Plan B has a higher dose and a different dosing regimen.
"When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under," the FDA said.
The FDA said Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a "rigorous labeling, packaging, education, distribution and monitoring program."
The Planned Parenthood Federation of America hailed the FDA's decision to make "emergency contraception" (EC) available to girls 18 and over -- but it expressed dismay at the "scientifically baseless restrictions" that deny younger girls access to "backup birth control."
"Today's announcement is an important victory and long overdue. Women need timely access to backup birth control -- last year alone, Planned Parenthood provided more than one million women with emergency contraception to prevent unintended pregnancy," said PPFA President Cecile Richards.
Richards said the United States has one of the highest rates of teen pregnancy in the western world -- so "anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy."
PPFA said its research shows that over-the-counter access to Plan B will not increase or encourage teen sexual activity; and it says studies show that women do not use Plan B as a regular method of birth control.
"Experts estimate that wide access to EC could prevent up to 1.5 million unintended pregnancies, and 800,000 abortions, a year," the PPFA website says.
The FDA said its decision to expand access to Plan B followed "an extensive process," including "expert advice" from a joint meeting of two FDA advisory committees and a public comment period.
The FDA also noted that the request to make Plan B over-the-counter for some women and prescription-only for others "raised novel issues."
Indeed, the Family Research Council has questioned whether the FDA has the legal authority to approve "dual status" marketing of the same dosage of a drug. The FRC also argued that the FDA lacks the authority to enforce an age restriction.
Focus on the Family believe the age restriction is worthless: "At best, it is unrealistic for the president and the FDA to believe teens won't have access to these pills and won't be at risk of exploitation; at worst, it is irresponsible for them to assume an age limit for the over-the-counter access is a safe and parent-respecting compromise."
President Bush on Tuesday surprised pro-life groups when he said, "I believe that Plan B...ought to require a prescription for minors, is what I believe." He also expressed support for the FDA's Acting Commissioner Andrew Von Eschenbach, who supports over-the-counter sales of pill.
Sens. Hillary Rodham Clinton and Patty Murray earlier placed a hold on Von Eschenbach's nomination as FDA commissioner, to speed up a ruling on Plan B.
See Earlier Story:
President Bush Inconsistent on Life Issue, Groups Say (22 Aug. 2006)
Subscribe to the free CNSNews.com daily E-Brief.
Send a Letter to the Editor about this article.
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