FDA Postpones Decision on Over-The-Counter Sales of Morning After Pill

National   |   Steven Ertelt   |   Feb 13, 2004   |   9:00AM   |   WASHINGTON, DC

FDA Postpones Decision on Over-The-Counter Sales of Morning After Pill

by Steven Ertelt
LifeNews.com Editor
February 13, 2004

Washington, DC (LifeNews.com) — The Food and Drug Administration has postponed a decision on whether or not to approve the over-the-counter sale of the so-called morning after pill, which pro-life groups say can sometimes cause abortions.

Barr Pharmaceuticals, maker of the Plan B drug, said the FDA has chosen to extend its review period before making a decision. The FDA was expected to make it’s decision by next Friday, but Barr says the timetable will be push back 90 days.

Barr spokesman Carol Cox said the FDA recently requested information from the company about how the drug affects teenagers. She said the FDA wanted more time to study the research.

That’s one thing that has pro-life groups concerned too.

If the drugs 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.

Abortion advocates criticized the FDA on Friday saying they feared the FDA would make a political decision to disapprove sale of the drug rather than relying on scientific evidence.

"This delay is a politically transparent roadblock," PPFA President Gloria Feldt said. "There is no scientific reason to make women wait even one more day. The delay announced today proves that anti-choice ideology is trumping scientific fact — at the expense of women’s health."

Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, disputed the contention.

In January, 49 pro-life members of Congress wrote a letter to President Bush, asking him to direct the FDA to prevent the "morning after pill" from being sold from store shelves.

Rep. Dave Weldon, a Florida Congressman who is a doctor by profession, wrote, "We are concerned that adolescent exposure to sexually transmitted infection will increase because of the availability of levonorgestrel over-the-counter. This availability may ultimately result in significant increases in cancer, infertility, and HIV/AIDS."

In December, an FDA panel recommended that the FDA allow the drug to be sold without a prescription.

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.

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

Related web sites:
Christian Medical Association – https://www.cmdahome.org