Teva Pharmaceuticals Wants to Lift Age Restrictions on Morning After Pill

VIDEO: University Hospitals Case Medical Centers Dr. Lisa Perriera comments.
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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."

Plan B Request Stirs Debate

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.

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