Historic step in the USA: FDA updates language on LNG ECPs mechanism of action
December 2022. In the United States, the Federal Drug Administration (FDA) just approved to change the label of Plan B One-Step (a levonorgestrel 1,5 emergency contraception pill) and its generic versions, in order to remove language suggesting that it prevents implantation of a fertilized egg.
Until now, and despite what scientific evidence and research has clearly shown for the past decade, the leaflet and patient information of this product (and its generics) said that the pill might work by preventing a fertilized egg from implanting in the womb (that is, after fertilization). The new text will state that it works before release of an egg from the ovary.
It must be noted that in Europe, this update on the language about mechanism of action was already proposed by HRA Pharma (manufacturer of Norlevo) and accepted by the European Medicines Agency (EMA), in 2013 (almost 10 years ago). The process to update the label in the USA begun in 2018, and has taken four years to be completed.
Congratulations to reproductive health and rights advocates in the US and to Foundation Consumer Healthcare (makers of Plan B) for this historic and long overdue achievement. The change has critical implications for EC access not only in the United States, but also for many other countries like Peru, where the label of Plan B was still used to restrict access to EC.
Visit FDA’s page “Plan B One-Step (1.5 mg levonorgestrel) Information” for more details.
