Today, the Food and Drug Administration decided to make Plan B, the morning-after contraceptive, available to everyone and lift the requirement that those under 17 years of age need a prescription. However, Health and Human Services Kathleen Sebelius rejected the decision, which means access is still restricted. Sebelius's statement says, "The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that [Plan B maker] Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."
The NY Times reports, "Under the law, Ms. Sebelius has the authority to overrule the agency, but no health secretary has ever done so, according to an F.D.A. spokeswoman. Her decision on an emotional issue that touches on parental involvement in birth control for teenaged children is likely to have powerful political reverberations in a presidential election season."
FDA Administrator Margaret A. Hamburg said, "I agree ... 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."
Advocacy group Reproductive Health Technologies Project's Kirsten Moore told the Washington Post, "We are outraged that this administration has let politics trump science. There is no rationale for this move. This is unprecedented as evidenced by the commissioner’s own letter. Unbelievable."
