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Teen girls under the age of 17 will still require a prescription for Plan B, the emergency contraceptive medication. Health and Human Services (HHS) Secretary Kathleen Sebelius has reportedly rejected Teva Pharmaceutical Industries' application to sell Plan B to teens without the age restriction.
FDA Commissioner Margaret Hamburg said the agency was prepared to grant Teva's request until they were directed by Sebelius not to.
If the FDA had approved, Plan B could have been sold on drugstore shelves next to other family-planning products like condoms.
Now, the pills will remain behind pharmacy counters with the same restrictions it had before. Women and teens 17 years and older will not need a prescription to get the medication, though they will have to provide ID to verify their age. The medication is still available to teens under the age of 17, but they will need prescriptions.
The pill, which costs around $50, can be used several days after intercourse. It contains hormones that can potentially stop unwanted pregnancies. Teva had aimed to lift the prescription requirement for the drug.
Sebelius said that switching from prescription to over-the-counter would require evidence that individuals, including young teens, can understand the product's labeling and use the pill appropriately. The HHS secretary said that Teva's application did not meet this standard.
This is not the first time that Plan B's age limitations have received scrutiny. A federal court in 2009 ruled that the FDA had based their restrictions on politics instead of science. They were ordered to reevaluate.
Plan B's opponents believe the drug could lead to increased promiscuity in younger teens. But, proponents of the pill think that requiring teens to get prescriptions for Plan B might end up preventing access to the medication. Some believe that giving teens access to Plan B would have helped curb the number of abortions and unwanted pregnancies nationwide.
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