Plan B: HHS Prevents Morning After Pill From Hitting Drug Store Shelves

Dec. 7, 2011— -- U.S. Department of Health and Human Services Secretary Kathleen Sebelius today blocked the Plan B morning after pill from hitting drug store shelves, countering recommendations from the U.S. Food and Drug Administration.

"Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional," Sebelius wrote in a statement.

FDA Commission Dr. Margaret Hamburg wrote in a statement that she believes there is adequate and well-supported data that shows Plan B One-Step is safe and effective for nonprescription use for all females of childbearing years – an opinion vetoed by Sebelius.

"Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women's Health, Inc.," Sebelius wrote.

Approval by the FDA would have landed the emergency contraceptive on drugstore shelves alongside condoms, spermicides and contraceptive sponges. Instead, women 17 and older can continue to buy the high-dose hormone pill over-the-counter, but girls younger than 17 still need a prescription.

The move has sparked outrage among some doctors, who say politics trumped science.

"The original FDA Advisory committee that recommended approval for Plan B, was virtually unanimous in its recommendation, and didn't find reason to draw a line at 18 or 17 or any age," said Dr. Paula Hillard, professor of obstetrics and gynecology at Stanford University School of Medicine. "Sebelius and Obama should be ashamed."

An HHS official told ABC News that Sebelius made the decision on her own and was not subject to political pressure by the White House.

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.

Teva Pharmaceutical Industries Ltd. , the maker of Plan B One-Step, requested Plan B's nonprescription status in February, citing label comprehension and safety studies that show that women of all ages can take the drug safely and effectively take this product.

"The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately," Sebelius wrote. "I do not believe that Teva's application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."

In a written statement, Teva Pharmaceutical Industries commended the FDA on its recommendation and expressed disappointment at the last-minute decision by HHS.

The morning after 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."