President Obama defended HHS Secretary Sebelius's decision yesterday to override the FDA's recommendation that morning-after contraceptive pills like Plan B be made available over-the-counter to women and girls of any age. Critics were accusing Obama of having directed the override in order to avoid controversy during the upcoming election. Obama today said that he wasn't in on the decision, but that he approved of it, "as the father of two daughters." As a result of the override, the drug will remain behind pharmacy counters, available without a prescription only to women over 17 years of age. Proponents of the FDA's plan saw its main advantage in putting the drug out on the pharmacy floor, where sexually active women could easily locate it, rather than in making it available to young girls; one expert observed that "not many 11-year-old girls" go into drugstores to buy anything, let alone single pills that cost $50.
Meanwhile in the UK the British Pregnancy Advisory Service is offering to make morning-after pills available free to women over 17 via post, after a preliminary telephone interview with a nurse ensures that they understand the pill's use. The charitable organization, which is the UK's largest abortion provider, is urging women to stock up in advance of the holidays, when unwanted pregnancies occur with higher-than-average frequency. The pills are sold online and in pharmacies to girls and women over 16, and are widely available, free of charge, in doctors' offices and NHS clinics.
Showing posts with label Plan B. Show all posts
Showing posts with label Plan B. Show all posts
Thursday, December 8, 2011
Wednesday, December 7, 2011
Plan B Availability Blocked by Sebelius
FDA Commissioner Margaret Hamburg has just released a statement on the FDA's plan to allow the emergency contraceptive Plan B to be sold over-the-counter to women and girls of all ages. FDA found the drug safe and effective for emergency contraceptive use, over-the-counter, for all women and girls of child-bearing potential. But then--this morning--came the politics. From Hamburg's press release:
"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."
"[T]his morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17."
Subscribe to:
Posts (Atom)