- Nov 25, 2001
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It's about time. This case is the sort of routine politicizing of our federal agencies that I've been complaining about non-stop for the past 8 years. There's a lot of things Bush and I disagree on, but this sort of stuff was just totally rampant during his two terms.
Great decision. :thumbsup:
Judge: 17-Year-Olds Can Have Plan B
Judge orders FDA to let 17-year-olds use Plan B pill without prescription
By LARRY NEUMEISTER Associated Press Writer
NEW YORK March 23, 2009 (AP)
The Food and Drug Administration let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication.
U.S. District Judge Edward Korman blasted the FDA's handling of the issue during the Bush administration, saying it had "repeatedly and unreasonably" delayed issuing a decision on the medication, marketed by Montvale, N.J.-based Barr Pharmaceuticals Inc. as Plan B.
Korman's ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions took action only to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.
"These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making," Korman said. "Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use."
He said the FDA's denial of nonprescription access without age restriction went against the recommendation of a committee of experts it had created to advise it on Plan B.
"And the commissioner ? at the behest of political actors ? decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews," Korman wrote.
Korman ordered the FDA to permit Barr Pharmaceuticals, which was bought by Israel-based Teva Pharmaceutical Industries Ltd. late last year, to make Plan B available to 17-year-olds without a prescription under the same conditions as Plan B is now available to women over the age of 18. He said his order must be complied with within 30 days.
The ruling came in a lawsuit brought by individuals and organizations advocating for wider distribution and access to emergency contraceptives, as well as parents and their minor children seeking access.
[...]
http://abcnews.go.com/Health/wireStory?id=7151963
Great decision. :thumbsup: