- The Washington Times - Tuesday, December 16, 2003

Advisers to the U.S. Food and Drug Administration yesterday recommended that a “morning-after pill,” taken within three days of unprotected sex to prevent pregnancy, be sold over the counter without a prescription.

Members of two advisory panels, the Reproductive Products Committee and the Non-Prescription Drug Committee, approved the recommendation by a combined 23-4 vote at a daylong hearing.

The FDA is not bound by the recommendations of its advisory panels, but it normally upholds them.

“There is a public-health imperative to increase access to emergency contraception,” said Dr. Vivian Dickerson, president-elect of the American College of Obstetricians and Gynecologists, which pushed to allow the change in law.

Pro-life and pro-family groups decried the decision yesterday.

“Only adherence to a pro-abortion ideology would explain any decision to make the morning-after pill as easy as baby aspirin for uninformed young girls to purchase,” said Tony Perkins, president of the Family Research Council.

“In the past, such as with the swift and politically motivated approval of the abortion drug, RU-486, the FDA has paid more attention to Planned Parenthood than to the real needs of American women and girls,” he added.

In an interview after the hearing, Dr. Sandy Kweder, deputy director of the FDA Office of New Drugs, said the agency has set a target date of early February for making a final decision on the Plan B brand of morning-after pill, an emergency contraceptive now sold in the United States by prescription.

Much of the public disagreement centers around how the morning-after pill — also known as an emergency or postcoital contraceptive — works. Some pro-life groups contend the drug works in part by preventing fertilization of the ovum and/or by preventing implantation of a fertilized egg into the uterus.

“We know that it inhibits ovulation. That’s its primary mechanism of activity,” Dr. Kweder said. “There are only minimal data on whether it inhibits fertilization or implantation.”

Wendy Wright, a spokeswoman for Concerned Women for America (CWA) who attended the hearing yesterday, said she came away convinced that the morning-after pill does prevent implantation — the medical definition of pregnancy.

CWA thus thinks the drug is an abortifacient that kills a human being, she said.

Five states — California, Washington, Alaska, Hawaii and New Mexico — already allow women to buy the morning-after pill directly from certain pharmacists without a doctor’s prescription.

The intent in the five states is to make it easier for women to obtain emergency contraception, especially on weekends and holidays, when a doctor might not be available.

Sales in those states are described as “behind the counter,” in which morning-after pills are kept not on the shelf alongside aspirin, vapor rubs and iodine, but in the pharmacist’s custody like prescription drugs, although sold upon demand.

But Susan Cruzan, an FDA spokeswoman, said the advisory panels’ advice to the FDA is to sell it over the counter.

In April, the Women’s Capital Corp., a D.C. firm that was the maker of Plan B, sought FDA approval to sell its version of the morning-after pill nationally over the counter. In October, Barr Laboratories Inc. announced it was acquiring Plan B from Women’s Capital. Although Barr still is in the process of buying the drug, it represented Women’s Capital at the hearing.

Yesterday, both Barr Laboratories and the American College of Obstetricians and Gynecologists, the nation’s largest gynecologists’ group, appealed to the FDA panels to allow the over-the-counter sales, a move they said would sharply decrease unwanted pregnancies and abortions.

Barr Laboratories says using Plan B within three days of unprotected sex can reduce the chance of getting pregnant by 89 percent. The quicker it is used, the more effective it is, the company said.

Two brands of emergency contraception, Plan B and Preven (manufactured by Gynetics of Somerville, N.J.) have been sold by prescription in the United States since 1998. Gynetics has indicated it also will apply to allow its drug to be sold without prescription.

Dr. Kweder said there are differences in the composition of Plan B and Preven.

Preven is a combination of birth-control hormones progesterone and estrogen, she said, and Plan B is just progesterone. The former, she said, can have some of the effects that opponents are most concerned about.

Dr. Kweder said all panel members called for definitive labeling so women can understand how Plan B works and whether they want to use it.

The FDA advisers say clear wording would require that women, particularly young girls, understand they should use the emergency contraceptive as soon as possible after unprotected sex, preferably within 24 hours, and that it does not protect against sexually transmitted diseases.

The FDA panelists also want labels to state that Plan B is a backup contraceptive that should not be used instead of routine birth control.

Barr Laboratories promised a massive consumer-education campaign, including a 24-hour hot line for advice on using the drug. Each one-time-use pack today costs $20 to $30.

The FDA says emergency contraception is very safe, having been used by 2.4 million American women and millions more in Britain and other European countries, where the pills are sold easily and without a prescription.

The Family Research Council held that the morning-after pill is “50 times stronger” than the birth-control pill.

“Yet over-the-counter access would allow women and girls to take this dangerous drug without any medical oversight,” Mr. Perkins said.

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