Details Emerge on Data Rejected in Morning-after Pill Decision

Internal FDA memos reported by the Washington Post last week show senior scientists at the FDA disagreed sharply with the agency's decision last month to bar the Plan B morning-after pill from over-the-counter sales. The scientists asserted that FDA officials applied a higher standard for determining Plan B's OTC status than has been applied to other drugs. Dr. John Jenkins, director of FDA's Office of New Drugs, wrote in an internal memo reported in the Wall Street Journal that Plan B is "fully consistent with the agency's usual standards for meeting the criteria" for OTC status. The FDA decision appears to rest on political implications of the drug rather than actual science. Jonca Bull, director of the Office of Drug Evaluation at the FDA, called some of the issues raised against the approval of Plan B "speculative and unbalanced," according to the Washington Post. The decision is also inconsistent with the evaluation of other forms of contraception, many of which are available over the counter. FDA scientists join a chorus of medical professionals and legislators in criticizing the decision. "The overwhelming data is that it is safe, effective and usable across age groups," said Vivian Dickerson, President of the American College of Obstetricians and Gynecologists." Plan B is most effective if used in the first 72 hours after intercourse. Since most unintended intercourse takes place over the weekend when women do not necessarily have access to a physician, medical professionals have adamantly supported the availability of Plan B without a prescription. The American Medical Association passed a resolution last week denouncing the FDA's decision. They also encouraged doctors to write advanced prescriptions for their patients. "This appears to be an unfortunate triumph of politics over science," said Senator Clinton (D-NY). She called the FDA decision "a sad example of the Administration pandering to its conservative base at the expense of women's health." A group of senators led by Sen. Clinton are seeking a Senate hearing and a General Accounting Office inquiry into the decision. "Through hearings and an investigation by the GAO we should be able to determine whether the FDA violated protocol and ignored scientific evidence to arrive at its decision. We also want to know if there was any intervention by the White House in this process," said Senator Clinton. Read Senate Request for Inquiry
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