Tuesday, September 08, 2009

Morning After!


I saw this a few days ago in a commercial, I had forgotten all about it becoming legal to use over the counter.

My source:
http://www.cnn.com/2009/HEALTH/04/22/plan.b.age/index.html

Plan B, also called the morning-after pill, is intended to prevent pregnancy after unprotected sex.

The Food and Drug Administration announced Wednesday that the contraceptive will be available over the counter to 17-year-olds, as it currently is for women 18 and older.

Agency spokesman George Strait said Thursday the approval process for the change will not take long. "It's likely to be weeks, rather than months or years before it's approved," he said.

The FDA just needs to review the label changes from the drug's maker, Duramed, Strait said. Once that's done, the approval will be complete.

On March 23, a federal court ordered that Plan B, an emergency contraception pill, be made available over the counter to those 17 and older, the agency said in a statement on its Web site. The agency will not appeal that order, the statement said.

In the order, U.S. District Judge Edward Korman also asked the agency to consider whether the pill should be available to women of all ages without a prescription, saying that such a determination is best left to the expertise of the FDA rather than a federal district judge. Watch more on the Plan B controversy »

And he rebuked the FDA for apparently departing from its own procedures with respect to making decisions on the pill's over-the-counter status, noting the "unusual involvement of the White House in the Plan B decision-making process."

The plaintiffs in the case presented "unrebutted evidence of the FDA's lack of good faith" toward the application to switch Plan B from prescription to non-prescription use, the judge wrote.

"This lack of good faith is evidenced by, among other things, (1) repeated and unreasonable delays, pressure emanating from the White House, and the obvious connection between the confirmation process of two FDA commissioners and the timing of the FDA's decisions; and (2) significant departures from the FDA's normal procedures and policies ... as compared to the review of other switch applications in the past 10 years," Korman wrote.

In August 2006, the FDA approved the sale of Plan B without a prescription to those 18 and older, but those 17 and under needed a prescription to obtain it.

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