FDA approves 'morning-after' pill without prescription

WASHINGTON — The federal government approved Aug. 24 the non-prescription sale to adults of Plan B, a "morning-after" pill for women that has abortion-causing qualities.

Pro-life and pro-family advocates responded with dismay and criticism to the announcement from a presidential administration that normally has sided with them in its policies regarding unborn human life.

The Food and Drug Administration's new policy will make Plan B available without a prescription for use by women 18 and older. Females 17 and under will need a prescription, a requirement previously for women of all ages. Plan B will be available for purchase at pharmacies and health clinics. It is to be kept in stock behind the counter at each pharmacy, so proof of age can be checked, according to the FDA.

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 "morning-after" pill, also known as emergency contraception, works to restrict ovulation in a woman. But 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.

The FDA's decision means a prescription will continue to be required for birth control pills but not for stronger doses of the same drug.

Critics said the new policy not only will destroy tiny human embryos but make it difficult to keep it out of the hands of underage girls and undermine parental rights in the process.

Southern Baptist ethicist Richard Land called it "a sad day for America."

"Allowing drugs with such powerful physiological and emotional effects to be sold over the counter to adults without a prescription will have significant consequences, none of them good," Land, president of the Ethics & Religious Liberty Commission, told Baptist Press.

"It will certainly result in the pharmacological, spontaneous abortion of large numbers of babies, who will be conceived but known only to God. Plan B will snuff out their lives before implantation can occur. Although no one will know whether conception occurred, and the Plan B-induced abortion will be at the earliest stages of the baby's development, it is still the medically induced ending of an innocent human life."

Wendy Wright, president of Concern Women for America, said the FDA "has no authority or ability to enforce an age restriction."

"Parents should be horrified that a drug like Plan B will be easier to get than a low dose of the same drug," Wright said in a written statement. "Their young daughters will now have this super-dose of hormones easily available, without any requirement for parental consent or medical oversight."

Both Land and Wright expressed concerns about the increased vulnerability of young girls to adult men as a result of Plan B's over-the-counter status.

"I am fearful that many adult men will purchase Plan B and use it in the seduction of girls who are not yet 18 and who cannot purchase the drug for themselves," Land said. "It will become part of the sexual predator's seduction kit. People who dismiss this scenario are simply unaware of the facts about the current relationship and dating habits between men 21 and older and younger girls in the United States. Plan B will be used by sexually predatory men to assure young girls that no pregnancy will occur.

"This decision will lead to increased rates of sexual activity for younger women outside of wedlock, resulting in physical, emotional and spiritual consequences, including increased rates of sexually transmitted diseases, against which Plan B offers no protection," he said.

Abortion-rights organizations such as the Planned Parenthood Federation of America and the National Abortion Federation applauded the policy shift but still criticized the FDA for not making Plan B available without a prescription to underage girls.

The FDA's previous rule "was not only medically unjustified, it was also a barrier to obtaining timely access to emergency contraception," NAF President Vicki Saporta said in a written release. She called the new guideline a "victory of science over politics" that was "long overdue."

Non-prescription sale of Plan B to adults seemed inevitable after President Bush appeared to signal Aug. 21 his support for a proposed change in the FDA policy.

The president told reporters at a White House news conference he believed Plan B "ought to require a prescription for minors." He also said he supported the recommendation of the FDA's acting head to permit non-prescription sale of the pill for adult women.

The FDA, with Andrew von Eschenbach as acting commissioner, announced July 31 it was working with Duramed, a subsidiary of Barr Pharmaceuticals, toward possible approval of Plan B on a non-prescription basis for women 18 and older. Barr previously had asked the FDA to approve over-the-counter sale of the pill to females 16 and older.

Bush appointed von Eschenbach as acting FDA commissioner last year.

In announcing its decision, the FDA said Duramed had agreed to monitor whether Plan B's age restriction is being followed by pharmacies. The program, which will be conducted twice in the first year and annually thereafter, will include the use of anonymous shoppers to determine if stores are selling the drug over the counter to girls under 18.

The FDA postponed last August a decision on Barr's request to sell Plan B over the counter. In May 2004, the agency rejected Barr's appeal for over-the-counter sales, citing a lack of evidence about the pill's effect on girls 16 and younger. It 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. Barr resubmitted its request under those guidelines.

When the FDA announced its delay of a decision last year, a question-and-answer document that accompanied the announcement included this statement in describing how the pill works: "If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation)." The Q and A released Aug. 24 did not include that statement.

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.