Feb. 25, 2011— -- Teva Pharmaceutical Industries Ltd. , the maker of Plan B One-Step, has requested that the U.S. Food and Drug Administration switch this "morning after" pill to full nonprescription status for women of all ages.
Currently, women 17 and older can buy the high-dose birth control pill over-the-counter, without a prescription. Those younger than 17 need a prescription to obtain the high-dose hormone pill.
"Our 2003 Plan B application and our current application for Plan B One-Step is seeking over-the-counter status for the product based on data that demonstrate the product meets the scientific criteria that FDA has established for over the counter products," said Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals. "Label comprehension and safety data show that all women are able to safely and effectively take this product. 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 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.
According to Jeff Ventura, a spokesman for the FDA, a prescription drug may be eligible for over-the-counter status if it is determined that dispensing the drug by prescription is not necessary for the protection of the public health, and the drug is safe and effective for use in self-medication as directed in proposed labeling.
"The application will go through the normal FDA review process," said Ventura in a statement. "It will be evaluated against the same scientific and regulatory criteria as all other over-the-counter switch applications."
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 of the pill after its scientific advisory board approved it.
No 'Good Rationale' for Age Restrictions
"There has never been a good rationale for having an age restriction," said Wood. "It's a very safe product, and it's good that the FDA is considering it, and I hope they'll be able to make a decision quickly. It would be one more tool in the toolbox."
That decision changed in 2008 when the FDA ruled that women 18 and older could buy Plan B over-the-counter. A year later, the FDA expanded the regulation to include those 17 and older.
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 even equate Plan B to an abortion pill, even though the 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."
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," said Vermeulen. "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."
Judgment vs. Efficacy
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," said Vermeulen. "The medications used in this product are used in oral contraceptives, which are prescribed safely to women under 17."
Nancy Northup, president of the Center for Reproductive Rights, said she applauds any action that will increase women's access to emergency contraception, but Teva's application does not absolve the FDA if its responsibility to comply with the court order.
"There's enough scientific evidence before the agency to decide whether to make Plan B available over-the counter, and there has been for 10 years," said Northup.
And Diana Zuckerman, president of the National Research Center for Women and Families, agrees that as long as the safety gives a green light, she supports the pill's availability.
"The FDA shouldn't make a decision based on what teen relationships should or should not be," said Zuckerman. "They should make decisions based on science."
And several scientists and doctors stand by the pill's safety.
But physicians still expressed concerns.
<"One significant issue for FDA in considering this request from the drug maker is going to be the impact of over-the-counter availability of this drug on what the agency refers to as 'help seeking behavior,'" said Dr. Scott Gottlieb, former deputy commissioner of the FDA and a fellow at the American Enterprise Institute. "In other words, the potential for an over-the-counter product to diminish the willingness or likelihood of someone seeking out other beneficial care."
Gottlieb said that the FDA will need to figure out if over-the-counter availability of Plan B for teen girls will reduce the likelihood of promoting healthy outcomes, such as safe sex practice discussions, the use of condoms and abstinence.
And Dr. Henry Miller, a Robert Wesson Fellow in scientific philosophy and public policy at Stanford University, agreed.
Plan B as 'Ex Facto Birth Control'
"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 Miller. "That would be undesirable, because they should be using barrier contraception to prevent sexually transmitted diseases."
While he doesn't have the data, Miller said he suspects that there is a significant demand for the drug in girls 17 and under, and 15-year-olds are probably not physiologically different from 17-year-olds.
"I'm making the assumption that a girl of 15 is emotionally capable of making the decision about a drug like Plan B without the required guidance of health care professionals," said Miller.
But Wright disagreed, and worried that the pill's availability would close off communication with parents and doctors.
"It's irresponsible to be making this drug easy for young people to get," said Wright. "And it could make women more likely to engage in unprotected intercourse."