Moldy Peaches

The Food and Drug Administration (FDA) is in the middle of a battle over morality that is dividing the United States. The FDA is siding with politics / religion over science and has continued to suppress access to the drug - Plan B® - due to tremendous pressure from the religious right.

Plan B® is an emergency contraceptive that can still prevent a pregnancy after contraceptive failure or unprotected sex.

A report released on Monday by the Government Accountability Office, an independent agency responsible to Congress, showed how top officials at the FDA last year overruled the scientists at their own agency and an independent advisory committee, and blocked an application to allow the pills to be sold over the counter. In fact, according to some of the key scientists involved, they were told that the application would be rejected "months before the staff had completed their reviews of the application."

Susan Wood, who quit as FDA's assistant commissioner for women's health over the Plan B® decision, said that the report was "a sad reminder of why I felt compelled to resign. Instead of improving and advancing women's health, the FDA leadership is ignoring its process and not relying on science and medical evidence."

What is even more shocking is that FDA officials, including the Director and Deputy Director of the Office of New Drugs and the Directors of the Offices of Drug Evaluation III and V, told scientists that they were told by high-level management that the Plan B® OTC switch application would be denied months before staff had completed their reviews of the application. The Director and Deputy Director of the Office of New Drugs told scientists that they were told by the Acting Deputy Commissioner for Operations43 and the Acting Director of CDER, after the Plan B® public meeting in December 2003, that the decision on the Plan B® application would be not-approvable. They informed scientists that they were also told that the direction for this decision came from the Office of the Commissioner. Both office reviews were not completed until April 2004.

Meanwhile in Canada - where science trumps politics / religion, this past spring, Health Canada announced without fanfare that Plan B®, the morning-after pill that is used as an emergency contraceptive after unprotected sex, would in future be available to Canadian women without a prescription.

"Women who need this product must have access to it very quickly or it will not be effective," Health Minister Ujjal Dosanjh said after Health Canada completed a review of clinical evidence and safety data for the drug."Allowing the product to be sold without a prescription will ensure that it is available to all women."

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