FDA complies with Plan B order

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When a judge talks, you listen. The FDA is dialing back restrictions on the so-called "morning-after pill"--a.k.a. Plan B, from Barr Pharmaceuticals/Duramed--so that 17-year-olds can get the contraceptive without a prescription.

Previously, FDA had limited the drug to 18-year-olds and up, who could get it "behind the counter" from a pharmacist. That policy came after three years of wrangling, because conservatives wanted Plan B restricted to prescription-only. At the time, FDA came under intense criticism from family-planning advocates, who said the delay, and ultimately the decision to bar younger women from behind-the-counter access, was politically motivated. Those groups eventually sued the agency.

And that's where the court order came in. A U.S. district judge agreed with the plaintiffs, saying that the agency's original decision was "arbitrary and capricious" and that FDA had been swayed by politics and ideology. The judge ordered the agency to make Plan B readily available to 17-year-olds, and to consider allowing access to younger girls. No word on that consideration yet, though the New York Times says the FDA won't take up the issue unless Barr asks it to.

- read the Washington Post article
- see the story in the New York Times

Related Articles:
Judge orders broader access to Plan B
FDA mulls behind-the-counter drug sales (2007)
After controversy, Plan B sales strong (2007)

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