Dr. Tom Roberts - September 30, 2005
F-D-A's Plan B
We know that the Bush administration values ideology over people’s real needs. This has always been the case, but it becomes more obvious as our world unravels a little further each day under his stewardship. Tax cuts for the rich while our states, and especially our gulf coast states have increasing needs. Political appointees and cuts in our Federal Emergency management programs while touting homeland security. Rhetoric about weapons of mass destruction and building democracy without any apparent appreciation of the real human and economic costs of invading a foreign country. An energy policy that favors big oil without any acknowledgement of the effects of global warming. Touting personal responsibility as a mechanism to meet the issue of health insurance, while the number of people in our country without access to health care continues to grow dramatically. These are not isolated decisions. This is a pattern of ignoring real human needs while pursuing a very different agenda.
Under this administration then, it should come as no surprise to see that the Federal Drug Administration, known as the FDA, has become a victim as well. The FDA is the government agency in charge of regulating prescription drugs and some non-prescription drugs in our country. Their work is supposed to be based on a scientific analysis of the safety and effectiveness of these medicines. Plan B is the name of a medication for emergency contraception, which has been available by prescription since 1999. Taking this hormone within 72 hours of unprotected, or poorly protected intercourse is a very effective method of preventing unwanted pregnancy. Time is of the essence, and it works better if taken within 24 hours. Having it readily and easily available determines how well it works. In 2003, the company that manufactures Plan B asked the FDA to change it from a prescription drug to an over the counter drug. This means that women could buy it without a prescription.
As they usually do in this type of situation, the FDA convened a panel of 28 experts to review all the information about Plan B, and to make a recommendation to the FDA. This committee voted 28 to 0 that the drug was safe and that it worked. 24 of the members of this panel voted that it should be made available without prescription. The four voting against acknowledged that their reasons were not related to safety or efficacy. The professional staff working at the FDA agreed with this panel’s assessment and recommendation.
Despite this, management at the FDA rejected the application for non-prescription use of Plan B. The stated reason was concern about the effect of easy access to Plan B on the sexual behavior of young teenagers. This, despite the fact that there was good information then that this has no effect on sexual behavior in teenagers. In fact the data clearly show that women with ready access to effective emergency contraception do not routinely use less effective regular contraception, do not engage more often in high risk sexual behavior, do not become more promiscuous, and do not have higher rates of pregnancy or sexually transmitted diseases. In other words, the stated reasons for denying women ready access to Plan B are not the real reasons.
I don’t think it takes much thought to see that the real reasons have nothing to do with safety, effectiveness or effect on sexual behavior. It is crystal clear that the FDA is bowing to the political pressure of the far right who could care less what science has proven. Their agenda does not include effective birth control for poor or disadvantaged women who don’t have ready access to the health care system. They don’t want teenagers to be able to make their own decisions about pregnancy, even if they make their own decisions about sexual activity. This administration and it’s supporters believe that they can and should impose their own belief system on the rest of us. The consequences are real and they are serious.
As an editorial in the New England Journal of Medicine this week pointed out, “This is a sad day for American women and the FDA.” Susan Wood who was the director of women’s health at the FDA has resigned in protest. Until now, the FDA has resisted political pressure to reflect any particular social ideology and has made it’s decisions based on scientific evidence. Their handling of Plan B has seriously damaged this reputation. The effects on interagency morale, professional and public trust, and more importantly on American women should not be underestimated.
But be aware. This is not an isolated event. It is just one more example of a pattern of governance that is out of touch with the needs of the people of the US and of the world. We don’t need to look very far to see the consequences.
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