Tuesday, November 15, 2005

Plan B - Wing-Nut Fundamentalism Applied to Your Family

From your Chicago Tribune:

Top officials at the Food and Drug Administration already had decided not to allow over-the-counter sales of a controversial "morning-after" contraceptive months before the agency's safety review was completed, according to documents and accounts from several FDA officials contained in a new critical audit of the agency's actions.

The Government Accountability Office, Congress' investigative agency, concluded Monday that the FDA did not follow its normal procedures in handling the application to allow women easier access to the emergency contraceptive pill, which is sold under the brand name Plan B.

Nearly two years after a scientific advisory committee recommended that the emergency contraceptive be made available to women without a prescription, the FDA has yet to make a final decision.

In a review of 67 applications that the agency received over the prior decade to allow over-the-counter sales of a drug, the GAO found that the FDA had not previously overridden a favorable recommendation by its scientific advisory committee. ***

Liberal critics have charged that the agency is dragging its feet for political reasons. Many social and religious conservatives oppose wider availability of morning-after pills. ***

The GAO report found evidence that a decision not to allow over-the-counter access was made within the office of then-Commissioner Mark McClellan early in the process, by late 2003.

The GAO report quoted two FDA officials who said they were informed that the application would not be approved as early as six months before the announcement, just after a December 2003 meeting in which a panel of outside experts voted 23-4 for approval. The two officials said Galson and another high-ranking FDA official informed them that the determination had come from McClellan's office. McClellan now heads the Centers for Medicare and Medicaid Services.

Also, the minutes of a Jan. 15, 2004, staff meeting showed that Galson told reviewers that a decision not to approve was "recommended." FDA staff members who were present provided documentation that they were told a decision not to approve already had been made, according to the GAO report, which did not detail what form that documentation took.

The FDA staff safety reviews, each of which recommended approval, were not completed until April 2004, the GAO said.The agency said Galson had told investigators he was not sure what decision he would make until shortly before he announced it in May 2004, but he also said he was "90 percent sure" he would turn down the application as early as January, the report said.

The rationale Galson gave--insufficient evidence on how over-the-counter access to the drug would affect the behavior of young adolescents--was "novel and did not follow the FDA's traditional practices," the GAO said.

And your Sun-Times reports that the FDA's scientific advisory committee "cited assessments that easier access [to Plan B] could halve the nation's 3 million annual unintended pregnancies."

That means that there have been almost THREE MILLION unintended pregnancies in the nearly two years since the FDA's scientific advisers recommended that Plan B be made available without a prescription.

That's three million (3,000,000) unintended pregnancies because conservative fundamentalism overrides medical science in this GOP FDA.

That's three million couples who's lives were unnecessarily turned upside down by political games played at the expense of America's families.

It's their fundamentalism forced on our families.

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