Sam Uretsky

Bureaucrats vs. Ideologues

On Nov. 14, the Government Accountability Office released a report about the Food and Drug Administration's rejection of the drug Plan B for over-the-counter sale. Plan B is an emergency contraceptive, sometimes termed the morning-after-pill. It is intended for use after occasions of condom failure, rape or bad judgment. The GAO noted that the FDA's rejection didn't follow the pattern of any other prescription to OTC switch:

"First, the Directors of the Offices of Drug Evaluation III and V, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter.

"Second, FDA's high-level management was more involved in the review of Plan B than in those of other OTC switch applications. For example, FDA review staff told us that they were told early in the review process that the decision would be made by high-level management.

"Third, as documented in the reviews of FDA staff and in our interviews with FDA officials, there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed.

"Fourth, the rationale for the Acting Director of [the Center for Drug Evaluation and Research]'s decision was novel and did not follow FDA's traditional practices. Specifically, the Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity compared to older adolescents."

While Julie Zawisza, an FDA spokeswoman, issued a statement saying that the FDA stood by its decision and questioned the validity of the GAO report, the agency's history and the nature of the drug indicate that the rejection was based on politics rather than science. Coincidentally, all of former agency commissioner Dr. Mark B. McClellan's emails and written notes on the subject had been erased or thrown out. Dr. Susan F. Wood, former director of the agency's office of women's health, resigned last August as a protest against the agency's delays in approving the emergency contraceptive.

Plan B is composed of 0.75 mg levonorgestrel, a synthetic hormone similar to the natural hormone progesterone. According to the manufacturer, the drug reduces the risk of pregnancy by 89% when used within 72 hours after intercourse, but the sooner it's used after intercourse, the more effective it's likely to be. For this reason, over-the-counter sale, which eliminates the delay imposed by obtaining a prescription, would be extremely valuable.

The drug has a high margin of safety, and the directions for use are quite simple. Its mechanism of action is to slow the movement of the egg and the sperm, preventing them from reaching each other.

It does not stop an existing pregnancy, and is not an abortion pill. According to the drug's manufacturer, over half of all abortions in the US are the result of contraceptive failure, so that easy access to Plan B would have a dramatic effect on lowering the number of abortions performed. It's also cheaper and safer than abortion, and because the drug prevents fertilization rather than ends a pregnancy, there's no reason to believe that it could cause the sort of remorse that abortion opponents warn can follow termination of a pregnancy.

Unlike contraceptives that prevent pregnancy by preventing implantation of a fertilized egg, levonorgestrel can't be considered a form of very early abortion. The decision not to approve over-the-counter sale of Plan B is based on ideology without regard for either medical or social considerations.

On the same day that the GAO issued its report on the irregularities of the Plan B disapproval, investigators at the Corporation for Public Broadcasting said they had uncovered evidence that its former chairman, Kenneth Y. Tomlinson, had repeatedly broken federal law and the organization's own regulations in a campaign to combat what he saw as liberal bias. That's two federal operations that have been dangerously politicized at their highest levels, and we've been saved only by the actions of the often maligned bureaucracy.

At various times, our democratically elected representatives have proposed rule changes to make it easier to fire public employees, or exempt jobs from civil service rules. Government employee unions have come under fire for insisting on job security in the face of declining tax receipts. But right now it seems that these people, who serve regardless of the party in power, remain our best hope for preserving democracy.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

From The Progressive Populist, Dec. 15, 2005

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