HHS Secretary Directs FDA Decision on Plan B

Plan B oral contraceptive (levonorgestrel 1.5mg), commonly known as the “morning after” pill, has been available for women over 17 for several years without a prescription.  The eventual granting of non-prescription status followed a long and somewhat tortured regulatory pathway quite uncommon for most drugs.

Recently, a decision on whether or not to extend availability of a particular product – Plan B One-Step – without a prescription has been under consideration by FDA during 2011.  Today, Dr. Margaret Hamburg released the following in a statement about the decision from the Center for Drug Evaluation and Research (CDER):

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence… CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.  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, as noted in her statement, today, Secretary of Health and Human Services (HHS) Kathleen Sebelius sent a memorandum to FDA Commissioner Margaret Hamburg regarding the supplemental new drug application for Plan B.

The memorandum states in part: I have carefully considered FDA’s Division Director Summary Review of Regulatory Action, dated November 30, 2011, for the supplemental application, which represents the position of the FDA and recommended approval of the application.  Based on my review, I have concluded that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.

The memorandum states that the label comprehension and actual use studies were not inclusive of all age groups that would be affected by the change.

The action, if not unprecedented, is highly unusual and raises a number of questions on many fronts and from many sectors.  Certainly for FDA-watchers, one of the most pressing involves assessing what impact, if any, this has on future FDA decisions?

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