In a move that appears to be testing the waters, the FDA on Thursday approved Plan B One-Step emergency contraception for sale to girls and women ages 15 and older without a prescription and said it no longer could be kept behind the counter.
The agency was quick to point out that this decision was of an amended application made by manufacturer Teva Pharmaceutical Industries ($TEVA) and is "independent" of a federal judge's ruling earlier this month that the FDA must make the contraceptive available to all females of reproductive age without any restrictions. The agency is still deciding whether to appeal that decision.
In fact, under the new rule the drug will come with lots of restrictions. The product will now be labeled "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified," the agency said. "Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer's age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft."
Teva made this application after the controversial move in 2011 by HHS Secretary Kathleen Sebelius to overrule the FDA's decision to make the so-called "morning-after pill" available to girls without restrictions. That led to a very public duel between Sebelius and FDA Commissioner Margaret Hamburg, who said FDA scientists concluded that it would be safe and effective for adolescent females to use Plan B. It was the first time an HHS chief had publicly contravened an FDA commissioner's decision and was largely seen as caving to political pressure.
Tuesday Hamburg said her decision was again based on science and that making the drug available could reduce the chance of unwanted pregnancies in girls and women after unprotected sex. The agency pointed out that "Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus."
According to NBC News, Planned Parenthood lauded the decision as a move in the right direction, while the Center for Reproductive Rights said it was not enough to address the barriers compromising women's rights.
- here's the FDA announcement
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