The FDA will not remove restrictions on access for the Morning After Birth Control Pill.
In a statement today, FDA Commissioner Margaret Hamburg said she was convinced that the product, called Plan B One Step, is safe and effective at preventing pregnancy after unprotected intercourse for women of all ages. Currently the product is available without a prescription only to those age 17 and over. As long ago as 2003, two FDA advisory panels recommended the product be made available over the counter without age restrictions.
Hamburg, however, was overruled by her boss, Health and Human Services Secretary Kathleen Sebelius. As a result, the drug makers’ application to remove the age restriction has been denied, and girls under age 17 will still need a prescription.
I would like to take this opportunity to request Sebelius resignation.
Margaret Hamburg’s statement is here. The most important part is here:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.