FDA Scientists Disagreed With Morning After Pill Sales Decision
by Steven Ertelt
June 18, 2004
Washington, DC (LifeNews.com) — Internal documents reveal that FDA scientists disagreed with a decision last month to disapprove over-the-counter sales of the "morning after" pill, which pro-life groups object to because it can sometimes cause an abortion and is dangerous for teenagers.
The FDA denied Barr Laboratories’ request because the pharmaceutical company failed to provide enough data about the impact of the drug on teens.
Barr’s main basis for approval was a study of 585 people who had used the drug. But, the FDA pointed out that only 29 of the subjects were 14-16 years old.
However, some FDA scientists "dismissed" the agency’s reasons for the ruling, the Washington Post reports.
Dr. John Jenkins, director of FDA’s Office of New Drugs, wrote in internal memos that the Plan B "morning after" pill is not dangerous for teenagers and that the agency subjected Barr’s application for OTC sales of the drug to more rigorous standards than it would other drugs.
According to the Post, he said the agency had never before considered young women’s use of oral contraceptives to be problematic.
Jenkins added that Barr’s application was "fully consistent with the agency’s usual standards for meeting the criteria" for OTC status.
Jonca Bull, head of the FDA office that oversees decisions to make drugs available without prescription, agreed. According to the Wall St. Journal, she wrote that concerns about sales of the drug were "speculative and unbalanced."
But pro-life advocates say the FDA scientists are wrong and point to numerous complications that young women can develop by using the drug.
If the drugs, which sometimes act as an abortifacient, are sold without a doctor’s approval, "It is likely that many women, particularly young women, would suffer physical consequences," said Dr. Gene Rudd, associate executive director of the Christian Medical Association.
"These high doses of hormones have not been adequately tested for their effect on teenagers, yet teenagers are a prime market for the drugs," Rudd said.
Cathy Cleaver Ruse, of the United States Conference of Catholic Bishops added that the morning after pill has been associated with a heightened risk of ectopic pregnancy, a potentially fatal condition.
Medical authorities in the U.K. and New Zealand have issued warnings about the drug’s dangers.
The drug can prevent the implantation of an unborn baby into the uterus following fertilization. As a result, the woman’s body artificially rejects the pregnancy and the unborn child is killed.
The FDA said Barr could resubmit the application with a caveat that customers purchasing the drug must be at least 16 years-old. Younger women would need a doctors’ order to be able to buy the pills.
Barr chief executive Bruce Downey confirmed that his company would do that.
Drugs such as Plan B are currently available in 101 countries, 33 of which do not require a prescription. It is also currently available in a limited number of pharmacies in five U.S. states (Alaska, California, Hawaii, New Mexico and Washington) without an advance prescription.
The AMA’s House of Delegates approved a resolution on Monday that said the Food and Drug Administration was wrong to have denied an application to sell the so-called morning after pill without a doctor’s visit.