[to top of second column]
And he said depositions by several FDA senior staff members revealed that political and ideological factors played an important role in the nomination and selection process of members of FDA committees that would recommend how the FDA should act on Plan B requests.
One doctor testified that the FDA commissioner's office appointed members to its advisory committee not for their expertise but to achieve a "balance of opinion," meaning they were very active in the anti-abortion movement, Korman said.
Still, the FDA's Advisory Committee voted 23 to 4 in 2003 to approve Plan B for over-the-counter status without age restrictions. However, out of nearly two dozen applications to move a prescription drug to over-the-counter status, the Plan B request was the only one not approved after the committee recommended it.
The judge said top FDA officials at a meeting in late 2003 or early 2004 told their subordinates that over-the-counter status for Plan B would not be approved at that time and that it was a decision that would be made at a higher level in the FDA than those decisions are usually made.
"Moreover, they were told that the White House had been involved in the decision on Plan B," he said.
"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 is a contraceptive that reduces the chance of pregnancy if taken within three days after sex. It contains a high dose of of birth control drugs. The drug works by preventing ovulation or by interfering with implantation of a fertilized egg. Opponents argue that is 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.
Barr is now owned by Teva Pharmaceutical Industries, a global company headquartered in Israel.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
< Recent articles
Back to top
News | Sports | Business | Rural Review | Teaching & Learning | Home and Family | Tourism | Obituaries
Law & Courts |
Spiritual Life |
Health & Fitness |
Calendar | Letters to the Editor