WASHINGTON -- The federal government will not challenge a judge's controversial ruling on the Plan B "morning-after" pill, meaning 17-year-old females will be able to obtain a drug with abortion-causing qualities without a prescription.
The U.S. Food and Drug Administration announced its decision in a brief statement April 22. The FDA notified Plan B's manufacturer, Duramed Research Inc., it could market the drug on a non-prescription basis to 17-year-olds upon the agency's approval of a request from the Pennsylvania firm.
The agency's decision barely met the 30-day deadline set March 23 by New York judge Edward Korman. Before Korman's ruling, Plan B was available without a prescription for use by women 18 and older. Females 17 and under needed a prescription, a requirement for women of all ages until a rule change in 2006.
Plan B is basically a heavier dose of birth control pills. Under the regimen, a woman takes two pills within 72 hours of sexual intercourse and another dose 12 hours later. The drug, also known as "emergency contraception," works to restrict ovulation in a woman. It also can act after conception, thereby causing an abortion, pro-lifers point out. This mechanism of the drug blocks implantation of a tiny embryo in the uterine wall.
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Southern Baptist ethics leader Richard Land decried the Food and Drug Administration's decision, saying it is "shameful that the Obama administration is not going to appeal this terrible decision" by Korman.
"The judge's ruling that 17-year-old girls can now get Plan B, post-intercourse contraceptives without a prescription from their doctor is one more example of the government thinking that it has the right to interpose itself between parents and their children," said Land, president of the Ethics & Religious Liberty Commission. "It also shows the senseless double standard with which the law addresses the abortion issue. In most schools, a 17-year-old girl can't get an aspirin from the school nurse without parental permission, but she can buy an abortifacient drug over the counter without a prescription or without parental notification to kill her potential child.
"The whole episode is shameful and dangerous," Land said. "Perhaps the most frightening thing about this whole episode is that the Obama administration doesn't seem to understand that."
Wendy Wright, president of Concerned Women for America, said the Food and Drug Administration's refusal to appeal was "driven by politics, not what is good for patients or minors. Parents should be furious at the FDA's complete disregard for parental rights and the safety of minors."
"Pregnancy counselors report that women are relying on Plan B as a regular form of birth control because it is easy to get," she said. "They are not aware that it is less effective than other methods of birth control and that it has not been tested to determine the effects of using it multiple times."
The FDA did not comment in its latest statement on another part of Korman's opinion in which he opened the door to pre-teens having access to Plan B. He directed the agency to decide "whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions." The Food and Drug Administration has the expertise to determine whether Plan B "may be used safely without a prescription by children as young as 11 or 12," Korman wrote in his 52-page opinion.
The FDA policy on Plan B presents the confusing situation of a prescription being required for birth control pills but not for stronger doses of the same drug.
In August 2005, the FDA postponed a decision on the request to sell Plan B over the counter before approving it with the 18-year-old age limit a year later. In May 2004, the agency had rejected an appeal for over-the-counter sales, citing a lack of evidence about the pill's effect on girls 16 and younger. The Food and Drug Administration gave the applicant an option of reapplying for over-the-counter sales for females 16 and older and prescription sales for girls 15 and younger.
The agency did not act in "good faith" in its consideration of the request, Korman wrote in his opinion. President Reagan nominated Korman to the federal bench in 1985.
FDA staff and officials agreed 17-year-olds could use the drug safely without a doctor's order, according to the record, Korman wrote. He therefore struck down the ban on non-prescription sales to 17-year-olds.
In its April 22 statement, the Food and Drug Administration said lowering the non-prescription age limit to 17 was in line with research results from its drug evaluation arm.
The FDA approved Plan B for sale by prescription in 1999. It had approved Preven, another "morning-after" pill, in 1998. Preven is no longer on the market, according to the agency.
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