Regulatory Focus™ > News Articles > One-Step, Step One: FDA Finalizes Approval of Teva's Plan B One-Step for Women of All Ages

One-Step, Step One: FDA Finalizes Approval of Teva's Plan B One-Step for Women of All Ages

Posted 20 June 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has finally announced the approval of Teva Women's Health's Plan B One-Step (levonorgestrel) for women of all ages, over the counter (OTC) and without a prescription, bringing to a close a case that has wound through the US' legal and regulatory systems for years.

Background: The Story so Far…

FDA initially approved Teva's proposal to make Plan B One-Step available OTC in December 2011, but was immediately overturned on 7 December 2013 by US Department of Health and Human Services Secretary Kathleen Sebelius, who said the decision lacked the necessary data to show the drug would be safe for use in its youngest potential users.

Women's health groups then filed a lawsuit against FDA and DHHS seeking to compel a reversal of the decision. Edward Korman, a justice on the New York circuit court, agreed with their argument, and on 5 April 2013 ruled that both agencies should permit the drug to be made available OTC to all women of reproductive age.

On 30 April 2013, FDA approved an amended application submitted by Teva in the aftermath of the original denial that allows Plan B One Step to be given to all women aged 15 and older on the condition that they show valid identification. Then, on 1 May 2013, the Department of Justice, acting on behalf of FDA, appealed Korman's decision, arguing that he lacked standing to overturn a regulatory decision. Korman rejected FDA's arguments in its appeal, but stayed his decision to allow FDA to appeal to a higher court, which it did in late May 2012.

Despite FDA's arguments, the appeals court issued the agency a major setback when it said it would only allow the agency to appeal Korman's decision on Plan B One-Step, but would not hear arguments regarding the original two-pill Plan B formulation, in effect approving it for sale.

In a surprising turn, FDA announced it would comply with the court's order on 10 June 2013, allowing Plan B One-Step to be marketed OTC to women of all ages. Under the plan formulated by FDA, the original two-pill formulation of Plan B will continue to be sold to so-called "older adolescents," and not to those of all ages based on FDA's understanding that there are "significant differences" between the two products and how they are used.

The plan had been open to some uncertainty, largely based on whether Korman would agree with FDA's understanding of the order they now said they would uphold, but Korman approved FDA's plan shortly thereafter.

Back to Step One

Now, in a 20 June 2013 announcement, FDA has confirmed the approval of Teva's supplemental new drug application for Plan B One-Step, effectively taking the agency back to 7 December 2011 when it first attempted to approve the drug for the exact same condition of use.

"The agency has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application," FDA wrote in a statement.

FDA - Order on Plan B

Tags: Plan B

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