Nov 21, 2005
On November 14, the Government Accountability Office, the GAO, reported that the Food and Drug Administration, the FDA, had ignored its own independent advisory committee and its staff – in order to block young women’s access to a pill preventing pregnancy.
At issue, was how top officials of the FDA handled the application by Barr Laboratories, maker of the contraceptive pill called Plan B, to sell this drug over the counter, rather than by prescription.
Barr had followed the FDA’s rules, providing evidence of the clinical safety and effectiveness of the drug. The scientific panel advising the FDA approved Barr’s request by a vote of 23 to 4. The professional staff of the FDA, many of them scientists, agreed. But the political hacks appointed by Bush to run the FDA turned down the application.
When the GAO looked further, it found that out of 67 drugs approved for a change from prescription to over-the-counter in the last 10 years, only Plan B was not approved.
The acting deputy commissioner and the director of CDER, the drug research center, told four staff members that Barr’s application would not be approved before they even looked at the evidence. When the GAO tried to investigate what the FDA commissioner had said about Plan B, they were told that all his correspondence had disappeared or been thrown out.
The current commissioner is indefinitely postponing Barr’s application, acting against the agency’s own regulations – all to make it more difficult for teenage women to prevent pregnancy.
In protest, the FDA’s Assistant Commissioner for Women’s Health, Susan Wood, resigned on August 31. Dr. Wood said, “I can no longer serve ... when scientific and clinical evidence, fully evaluated and recommended for approval by professional staff here, has been overruled.”
A majority of Americans, in every poll taken, believe a woman should be the one in control of her own body and the contraceptive methods that allow her to avoid pregnancy. So these political hacks had to come up with excuses and delays, ignoring their own rules, their own staff, and scientific evidence to support views of their minority supporters, the religious right.
These religious attitudes go back three hundred years to the days of the Salem witch trials, when women were supposed to be silent and pregnant, under complete control by their husbands. Christianity had a long history of torturing to death those who disputed its views and its control. The religious right here in the U.S. today sounds just like the Jewish rabbis in Jerusalem or the Catholic pope in Rome or the Islamic mullahs in Tehran.
This arrogant minority pretends to speak for us, to shut us up, to prevent us from making our own decisions. We can’t let them.