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Regulatory Focus™ > News Articles > FDA Declines to Take Action Against Unusual 'Plan B' Distribution Scheme

FDA Declines to Take Action Against Unusual 'Plan B' Distribution Scheme

Posted 30 January 2013 | By

In the waning days of 2011, US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius conducted an unprecedented action when she ordered the US Food and Drug Administration (FDA) to overturn its finding that Plan B (levonorgestrel) would be safe and effective for over-the-counter use for those under the age of 17. But now FDA has signed off on an agreement that could soon see the pill being dispensed at an unusual location: vending machines.

That decision, first reported by Public Opinion, pertains to so-called "Plan B vending machines" that numerous colleges are eyeing as a means of making emergency birth control products more available to their students. Under the proposal, the vending machine would be available to students who would only be required to pay $25 for the drug.

But that easy availability had raised troubling questions for critics. Namely, if a student under the age of 17 is enrolled at a university-or is simply present at a university-wouldn't they be able to access the drug? This, they argued, would violate Sebelius' 2011 directive against its OTC use for those under the age of 17.

However, the first school in which the vending machine is allowed, Shippensburg State, does not have any students under the age of 17, and would thus not run afoul of those rules, FDA found. The machine will also be located in a student-restricted area and require a student ID to access, Public Opinion reported.

"FDA looked at publicly available information about Shippensburg (University's) vending program and spoke with university and campus health officials and decided not to take any regulatory actions," FDA spokeswoman Erica Jefferson said in a statement to Public Opinion.

Other colleges, including Towson University, are reportedly evaluating similar programs at their institutions. 

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