In a stunning decision, the Health and Human Services Department has ordered the Food and Drug Administration to deny an application to make the emergency contraceptive Plan B One-Step available over the counter without a prescription to women of all ages. Currently, Plan B One-Step and the generic brand Next Choice are available behind the counter to women 17 and older -- meaning that they do not need a prescription but they have to ask a pharmacist for the drug. Those 16 and younger need a prescription in order to obtain it.
The FDA was set to remove the age restriction, based on the scientific data before it, but HHS intervened to stop it. From FDA Commissioner Margaret Hamburg:
I reviewed and thoughtfully considered the data, clinical information, and analysis provided by [the FDA's Center for Drug Evaluation and Research], 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.
What should have been a routine decision based on sound scientific and medical evidence just got hijacked by politics -- again. Some may recall that the Bush administration dragged its feet for years on whether to make emergency contraception available over the counter without a prescription. The political compromise it struck was to require a prescription for adolescents only.
That has led to barriers not just for teens but for adults as well. Women do not always know where to find emergency contraception, are embarrassed to ask for it, are told they need a prescription by pharmacists who do not understand the law, or are turned away by pharmacists who disapproved of it.
With emergency contraception, time is of the essence. A woman who fears she might become pregnant needs fast access, not delays at the pharmacy counter.
This piece was originally posted on ThinkProgress.