FDA Again Postpones OTC Decision on Plan B Morning After Pill

National   |   Steven Ertelt   |   Aug 29, 2005   |   9:00AM   |   WASHINGTON, DC

FDA Again Postpones OTC Decision on Plan B Morning After Pill Email this article
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by Steven Ertelt
LifeNews.com Editor
August 29, 2005

Washington, DC (LifeNews.com) — The FDA on Friday again postponed a decision on whether or not to allow sales of the morning after pill, which sometimes causes abortions, over the counter. Barr Laboratories, the maker of the Plan B drug, wants to be able to see it directly to women over the age of 16 while requiring younger teens to still obtain a prescription from a doctor beforehand.

The agency indefinitely postponed the decision saying the unusual request of selling the drug over the counter to some women, but not all, "presented us with many difficult and novel policy and regulatory issues."

"In some cases, the questions we were asked to answer were unprecedented for this agency," FDA Commissioner Lester Crawford said in a statement.

"These are profound regulatory decisions that cut to the heart of our work," he added. "The answers to these questions can establish very broad and far-reaching policies that could have a significant effect on the way FDA regulates many different drugs."

Abortion advocates have been heavily lobbying the FDA to approve the drugs for sale without a physician’s visit and condemned the decision.

"I am stunned and outraged and furious," Sen. Patty Murray, a Washington Democrat, said. "This is not only a broken promise to us, but another frightening example of politics trumping science at the FDA."

But pro-life groups say the drugs expose teens to risky sex and add that studies show they don’t reduce pregnancy or abortion rates.

"I believe the FDA is being sensitive to the fact that this drug is not like others," Wendy Wright of Concerned Women for America said.

"How can you make it available (over-the-counter) for most women and not have it get into the bodies of girls for whom it has not been approved without prescription? This will allow more people into the process of making that assessment," she explained.

Crawford said his agency would allow for further public input and involvement in the decision-making process, but he lowered the length of time to 60 days from the usual 90 to 120 days.

Women can already obtain the morning after pills over the counter in seven states, including Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington.

Crawford said the FDA’s drug center has examined research and information about the drugs’ effect on teens and concluded that Plan B is safe to use as an over the counter product, but only for women who are 17 years of age and older.