FDA Advisory Panel Recommends Morning-After Pill for OTC Sales
by Steven Ertelt
December 17, 2003
Washington, DC (LifeNews.com) — It didn’t take long for a Food and Drug Administration advisory committee to give the go-ahead, on a 23-4 vote, to sell the morning after pill over the counter rather than only via a prescription.
Backers of the drugs claimed that they could reduce unintended pregnancies and abortions.
"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.
The makers of "Plan B," and abortion advocates, say it is an emergency contraception that be taken within 72 hours of having sex to stop pregnancy.
However, pro-life groups say the pills sometimes cause an abortion.
Plan B because, like another "morning-after" pill called Preven, can prevent the implantation of an unborn child into the uterus following fertilization, forcing the body to artificially reject the pregnancy and killing the newly-conceived unborn child.
"In the case of the morning-after pill, it has proven in some cases to act as an abortifacient. When this occurs, we have no choice but to oppose its use and err in favor of protecting life," said Arizona Right to Life in a statement.
Cathy Cleaver Ruse, Director of Planning and Information for the USCCB Secretariat for Pro-Life Activities, agreed. "A drug which destroys human embryos and puts women at greater risk of ectopic pregnancy does not belong on the shelves of a drug store. American women and children do not deserve this reckless experiment on their lives."
The FDA doesn’t have to follow the recommendations of its advisory panels, though it usually does. A decision by the FDA is expected by mid-late February.
If the FDA approves over the counter sales of the drugs, they would only be sold in stores that have a valid pharmacy or drug wholesale license — not convenience stores.
Some of the members on the FDA advisory committee said they wanted teenagers’ use of the drugs limited and they argued there hasn’t been enough study of the drugs effects on teens.
"I’m concerned there will be an exploitation of young women’s fears about becoming pregnant,” leading them to overuse the pills, said panelist Dr. Susan Crockett, a Texas gynecologist and director of maternity services at CHRISTUS Santa Rosa in San Antonio.
"If you remove the need for a patient to talk to me, you remove my ability to help them," Crockett said.
Dr. John Bruchalski, speaking for the Catholic Medical Association, agreed. "Without medical advice, the use of Plan B by teens will be disastrous," he said.
However, most panel members said the FDA couldn’t enforce any guidelines preventing or limiting teen use of the drugs if they are sold over-the-counter. States could be open to passing laws limiting their use, depending on the final outcome from the FDA.
Some on the panel wanted the company to remove information accompanying the drugs saying they do not cause abortions.
Pro-life groups also say the drugs are harmful to women.
"Approving over-the-counter access to a high dose of this drug, when a lower-dose cannot be obtained without a medical exam, physician oversight and prescription, exposes women, teen-agers and girls to complications such as blood clots and heart attacks," explained Wendy Wright of Concerned Women for America.
Forty-four members of Congress wrote to the FDA last week saying the drug should not be available over the counter.
The drug involves the use of two tablets, one taken 12 hours after the other. The drugs contain a much higher dosage of progestin, the hormones used in birth control. The drugs cost $25-30, though a price hasn’t been set for over the counter sales.
Five states, including Washington, California, Alaska, Hawaii and New Mexico, already allow women to buy the drugs directly from pharmacists, though they are not on the shelves of stores. It is sold without a prescription in 33 countries.
Whether the FDA approves the drug for over the counter sales may be irrelevant. At least one Internet web site sells Plan B online. Women purchasing the drug complete an online consultation that doctors review. If approved to buy the drugs, they are shipped in discreet packaging.
You can contact the FDA to voice your opinion on making Plan B an over-the-counter drug. The phone number is 888-463-6332.
Related web sites:
Food and Drug Administration – https://www.fda.gov