Breaking: Sebelius overrules FDA – morning-after pill will NOT be made available to kids without a prescription
Here’s the letter from FDA Commissioner Dr. Margaret Hamburg. Excerpt:
I reviewed and thoughtfully considered the data… and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, this 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.
Abortion proponents are in shock. So am I, although in the opposite direction. From Bloomberg:
The decision follows by two years a federal court ruling that age restrictions on the pill were arbitrary, based more on political pressure than safety.
This was the same charged leveled against President Bush’s FDA for dragging its feet to make Plan B freely available to adults.
Now what can proponents say?
Nevertheless, I await the other shoe to drop. Perhaps there is just a technical glitch. We’ll see.
UDPATE: Here’s Sebelius’s letter. It states studies have not been conducted on all ages to determine the impact of a megadose of female steroids on the adolescent female body.