Judge: FDA must revisit 'morning-after' pill

WASHINGTON — A federal judge has ordered the Food and Drug Administration to re-evaluate its age restriction on the non-prescription sale of Plan B, making it possible pre-teens may have access to a "morning-after" pill that has abortion-causing qualities.

In his March 23 ruling, Edward Korman of New York directed the FDA to make the drug available over the counter to 17-year-olds within 30 days. He also instructed the agency to decide "whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions." The FDA has the expertise to determine whether Plan B "may be used safely without a prescription by children as young as 11 or 12," he wrote in a 52-page opinion.

Before Korman's decision, 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, known as the "morning-after" pill or "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.

Pro-life advocates decried the judge's ruling, saying it will result in the destruction of embryonic human beings, undermine parent-child relations, endanger minors' health and make girls more vulnerable to sexual exploitation and abuse.

"This unwarranted and intrusive decision by a federal court judge into medical decisions that he acknowledges in other circumstances are best left to the medial expertise of the FDA is alarming," said Richard Land, president of the Ethics & Religious Liberty Commission. "It is illustrative of both the increasing disregard for preborn human life, in that Plan B's purpose is to prevent any life that may have been conceived from continuing its existence, and the increasing intrusion of the federal government into decisions which should be between parents and their children."

Wendy Wright, president of Concerned Women for America, said the decision "puts politics above women's health, and intrudes into parents' ability to protect their minor daughters."

"Even advocates for the morning-after pill have admitted, since the FDA's [2006] decision, that Plan B is not as effective as they originally claimed," Wright said in a written statement. "Making the morning-after pill easy to get has not resulted in fewer pregnancies or abortions, as advocates promised it would. Pregnancy counselors report more young women relying on it as a regular form of birth control — even though the drug has not been tested to discover what happens when it is used multiple times."

Denise Burke, vice president of legal affairs for Americans United for Life, said in a written release, "Increasingly easy access to Plan B may have severe and unintended consequences such as the continued exploitation and sexual abuse of young girls. It is all too easy for this unsafe drug to be used by sexual predators and even the victims themselves to hide the abuse from parents and the authorities."

The FDA postponed in August 2005 a decision on Barr Pharmaceuticals' 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 Barr's appeal for over-the-counter sales, citing a lack of evidence about the pill's effect on girls 16 and younger. The FDA gave the company an option of reapplying for over-the-counter sales for females 16 and older and prescription sales for girls 15 and younger.

The FDA did not act in "good faith" in its consideration of Barr's request, wrote Korman, a 1985 nominee by President Reagan.

"The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays," Korman wrote.

"These political considerations, delays and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making," he said. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedure regarding similar applications to switch a drug product from prescription" to over-the-counter sale.

FDA staff and officials agreed 17 year olds could use the drug safely with a doctor's order, according to the record, Korman wrote. He therefore struck down the ban on non-prescription sales to 17 year olds.

Abortion-rights advocates applauded the ruling, at least some welcoming the potential for extending Plan B's over-the-counter availability to younger girls.

"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard their health not undermine it" said Nancy Northup, president of the Center for Reproductive Rights, in a written statement. "Emergency contraception is proven safe and effective and today, we have succeeded in expanding access to 17 year olds and are one step closer to making it fully available to all women, including young women for whom the barriers — and the benefits — are so great."

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.

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 FDA.