Most of the news reports focus on the order to make MAP available without prescription to 17 and older within 30 days--that order rolls back the entirely baseless change on the part of the agency from a cutoff age of 17 to 18--but the real news is that the court is sending the decision back to the FDA to reconsider whether it should be completely over-the-counter.
Full decision (a rip-roaring tour of the Bush administration's 8-year war on the MAP) available here: http://ccrjustice.org/newsroom/press-releases/court-orders-fda-reconsider-decision-morning-after-pill-restrictions
Oh, it has everything, threatened firings, disgusted resignations, scientific staff refusing to sign decisions forced on them by upper management, purged internal minutes, mysterious pressure from the White House, scientific panelists added by fiat because of their right-to-life credentials, and two really irritated judges.
Jenny Brown
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Judge orders FDA to allow 17-year-olds to get morning-after pill
The Associated Press 4:08 PM EDT, March 23, 2009
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.
The lawsuit was filed in 2005 by the Center for Reproductive Rights and others after the FDA denied a petition asking it to make Plan B available without a prescription to women of all ages. "Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, president of the center.
Assistant U.S. Attorney F. Franklin Amanat, who argued the case for the government, said: "We're studying the decision and evaluating options." "We need to discuss it with the agency and figure out what our next steps will be," he said.
The government in court papers has said politics played no role in the agency's decisions.
Plan B reduces the chance of pregnancy if taken within three days after sex. It works by preventing ovulation or fertilization and interfering with implantation of a fertilized egg, which some people consider the equivalent of abortion.
In 2006, the FDA allowed Plan B to be sold without a prescription to adults, but only by pharmacies that checked photo ID before selling the pills. Girls 17 and younger were required to obtain a prescription.