Plan B: FDA Considers Putting Morning After Pill on Drug Store Shelves

Agency will decide today whether to expand nonprescription access to drug.

Dec. 7, 2011— -- The Food and Drug Administration is expected to decide today whether to switch the Plan B morning-after pill to nonprescription status for women of all ages -- a move that would land the emergency contraceptive on drugstore shelves alongside condoms, spermicides and contraceptive sponges.

Currently women 17 and older can buy the high-dose hormone pill over-the-counter, but girls younger than 17 need a prescription.

Teva Pharmaceutical Industries Ltd. , the maker of Plan B One-Step, requested the switch in February.

"Label comprehension and safety data show that all women are able to safely and effectively take this product," Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals, told ABC News at the time. "It is not typical for any women's health product to have age restrictions."

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of the uterus if taken within 72 hours of unprotected sex. The drug is not effective if the woman is already pregnant, and it does not pose harm to a fetus.

The pill has been a source of controversy for years. Susan Wood, director of the Jacobs Institute of Women's Health in Washington D.C., stepped down from her position as the assistant FDA commissioner for women's health in 2005 after strongly disagreeing with the FDA's decision to delay over-the-counter access to the pill after its scientific advisory board approved it.

In 2008 the FDA ruled that women 18 and older could buy Plan B over-the-counter. A year later, the agency expanded the regulation to include those 17 and older.

"There has never been a good rationale for having an age restriction," Wood told ABC News in February. "It's a very safe product, and it's good that the FDA is considering it."

Wood, who has a young teenage daughter and "blanches at the thought" of her needing Plan B, still strongly supports the product.

"I understand the nervousness," she said. "It raises the specter of why would she need it? But the bad thing already happened, and the first step is to make sure she's not pregnant and then deal with the other issues later."

But other groups staunchly protest the over-the-counter selling of Plan B. And some religious conservatives equate Plan B to an abortion pill.

Wendy Wright, president of the conservative public policy group, Concerned Women for America, has spoken out against over-the-counter use of Plan B in the past. She said it's inappropriate for a high-dose birth control pill to be over-the-counter, considering regular birth control pills are given by prescription only.

While Wright is not opposed to prescribed birth control pills, she said that Plan B "needs medical oversight. The same act that concerns them that they might be pregnant may cause them to get an STD."

Plan B Request Stirs Debate

Dr. Lee Vermeulen, clinical professor of the University of Wisconsin-Madison School of Pharmacy, said that much of the protest against or advocacy for the decision to expand the availability of Plan B depends on how a person feels about the reproductive freedoms and the rights of adolescents and young adults.

"If one believes that only women who are 17 and older have the right to decide whether or not they get pregnant, then there is clearly no reason to lift the age restriction," Vermeulen said in February. "If one believes that any woman of child-bearing age should have the right to choose for themselves, it would be necessary to recognize that women under 17 are biologically able to conceive, and therefore the age restriction should be lifted."

But many argue that it is not the FDA's place to weigh in on judgments and ethics, but only on the safety and efficacy of the drug.

"I am not aware of any clinical reasons why this product would be unsafe or ineffective in women under 17," Vermeulen said. "The medications used in this product are used in oral contraceptives, which are prescribed safely to women under 17."

But some doctors are worried easier access to the morning after pill will mean fewer teens practicing safe sex.

"The greatest hazard I see is that under-17s would begin to use Plan B as a kind of ex post facto birth control method," said Dr. Henry Miller, a Robert Wesson Fellow in scientific philosophy and public policy at Stanford University. "That would be undesirable, because they should be using barrier contraception to prevent sexually transmitted diseases."