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The Food and Drug Administration, for all its faults, has largely preserved a dispassionate scientific sobriety above the tides of public philosophy. In fact, its earliest incarnation was a humorless little office called the Bureau of Chemistry, which was created by President Lincoln in 1862 and headed by an actual chemist. In later years, the FDA would regulate tea importation, penicillin and a polio vaccine with an impressively unsympathetic eye. In 1959, with almost Grinchian relish, they recalled the entire U.S. cranberry crop three weeks before Thanksgiving.
Yet today, Plan B sits not on a Rite Aid shelf, but in a bureaucratic holding pattern that will likely endure for years. After being recommended for approval at every level of its formal review, the pill mysteriously ended up in what is called a “rulemaking process” to determine whether the product can be given “dual status,” which would make it available without prescription for adults but not for minors. FDA staffers say this is simply a way to ensure that Plan B stays in purgatory (for a few more election cycles, one could imagine.) Wood took the strongest stance, resigning in protest on August 31. — Will Doig What is the function of the FDA’s Office of Women’s Health? In the case of Plan B, the FDA decided to solicit public comment about whether it should be available without prescription. What’s the value of getting input from a public with no medical expertise? What’s wrong with that?
took several years to develop the rules and regulations to ensure that an FDA-certified mammography facility is in fact a good one. In this case, it’s an abuse of the system. We’ve had multiple products out there on dual status, and we’ve never felt the need to go through rulemaking on them before. But for some reason, this time we announce that instead of approving [Plan B], which is what the evidence says we should do, we’re going through rulemaking. It sounds like just sixty days of public comment, but that’s just the first one percent of how long this is going to take. It’s a very big deal to pass a regulation. It’s going to be years before we get through this. Recently, we’ve witnessed what seems to be an ideological drift in women’s health issues — abstinence education, parental notification laws, etc. Is this part of that?
The FDA is part of Health and Human Services, which is run by the executive branch of the federal government. The delay of Plan B is certainly in step with this executive’s ideology, don’t you think? If historically the FDA has been able to maintain that wall of independence, why does it seem to be coming down now? When it’s reported that “the FDA made this decision,” who exactly are they talking about? Who is “the FDA?” Who appoints the commissioner? And Lester Crawford, who was commissioner when the decision to start a rulemaking process for Plan B was made, has since resigned.
He was appointed by the current President Bush? The FDA is not involved in national security or anything like that. Why does it seem to be such a shadowy organization? Why isn’t this process more transparent? Critics of emergency contraception say that it could encourage unprotected sex, thereby increasing the likelihood of STD transmission. Is it the FDA’s place to consider hypotheticals like this? American Life League Director Julie Brown says Plan B contains a chemical that can contribute to heart problems and blood clots. Do you know what chemical she’s referring to? The U.S. Bishops Pro-Life Secretariat has said that Plan B can also be used as an abortion pill, after conception, by impeding the movement of the new embryo through the fallopian tube. Medically speaking, is this considered abortion?
DISCUSSION FORUMS: The politics of abortion – where are we headed? The morality of abortion – where do you stand?
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