US Health and Human Services Secretary Kathleen Sebelius has overruled the Food and Drug Administration (FDA), and today ordered it reject the application from Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) to allow it to sell its Plan B One-Step 'morning after' contraceptive pill without a prescription.
In February this year, Teva asked the FDA to allow women of all ages to buy the pill without prescription, after claiming to have demonstrated that correct use of the pill was safe and effective for young women.
The FDA acceded to the request, and decided that the pill should be sold over the counter without prescription to women of all ages, but Sebelius overruled that decision, on the grounds that it was not certain that girls aged 17 and under would understand the medical implications of taking the pill. This means that policy in the US will remain the same, and that the pill will be for sale without prescription only to women over the age of 17. The matter will probably go to court.
Teva said in a statement, "We commend the FDA for making the recommendation to approve providing women with increased over-the-counter (OTC) access to Plan B One-Step, and we are disappointed that at this late date, the Department of Health and Human Services has come to a different conclusion. We have not yet received the Complete Response Letter at this time. We will review the letter when we receive it and then determine our next steps."
Published by Globes [online], Israel business news - www.globes-online.com - on December 7, 2011
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