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WASHINGTON — The Food and Drug Administration will decide on Wednesday whether to remove merchandising restrictions on the emergency contraceptive Plan B and allow the product to be merchandised in the front-end without age restrictions, according to a report published Monday in the Washington Post.
According to the report, Teva Pharmaceutical Industries requested that the FDA relax merchandising restrictions based on two new consumer usage studies showing that pre-teen and teenage women appropriately self-selected use of the emergency contraceptive. One study involving 335 girls ages 12 to 17 years showed that between 72% and 96% of them understood the proposed package label well enough to use the drug safely and effectively on their own. The second study, involving about 300 girls ages 11 to 16 years, showed that they could use the product properly and safely, according to Teva.
Separately, a hearing is scheduled for Dec. 13 on a motion to declare the agency in contempt of court for failing to review its decision to leave age restrictions in place as part of a suit filed against the agency by the Center for Reproductive Rights.
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