OP-EDS

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May 15, 2004

FDA plays God and denies Plan B access

As if it isn't bad enough that the Federal Communications Commission (FCC) has been raining down its fire and brimstone morality on the American public, the Food and Drug Administration (FDA) rejected a proposal earlier this week to allow over-the-counter sales of a morning-after abortion pill, in an unusual move that appears to be motivated by the current administration's conservative agenda.

Honestly, it's like you give an agency a fancy three-letter abbreviation and they start confusing it with G-O-D.

A good amount of ink has been spilled about Bush's religious convictions and their effect on issues like stem cell research and abortion, and perhaps he has the right to allow his beliefs to influence his political policy. When it comes to releasing a means to prevent thousand upon thousands of unwanted pregnancies, though, the government's responsibility should lie with their concern for the public's bodies, not their souls.

In fact, FDA scientists have admitted that they are worried that younger citizens will have more unprotected sex if offered a reliable means to control pregnancy, thus leading to the spread of more STDs. While this may or may not be true, it is a behavioral argument that has never nor should ever fall under the purview of the FDA. And since the FDA cannot preach their mind, despite their good intentions, they've managed to concoct some wacky alternatives to the truth.

Although an advisory committee voted 23 to 4 to allow the morning-after pill called Plan B to be sold without a prescription, the FDA concluded that the data for younger women was insufficient to approve the drug for the general public. Barr Research, the pharmaceutical company that manufactures Plan B, then proposed marketing the drug as prescription for women under the age of 16 and as nonprescription for women beyond that not-so-innocent-anymore age. The FDA response: We first need to see how you would label the box.

If I were Barr Research, I would send the FDA a memo saying, "In response to your concerns, we've decided to change the name from ‘Plan B' to ‘Plan For Some Daycare If You're Under 16,' in big red letters on the front of the package."

This lame excuse makes invading Iraq because of Saddam's ties to al Qaeda look like a Euclidean proof. If our leaders continue to allow their moral indignation to influence the course of legitimate scientific research, they should be honest about it or, at the very least, get a better spin artist down to the FDA to come up with a plausible shtick.

"I'm not trying to convey this decision as being common or usual," Dr. Steven Galson, acting director for the FDA's Center for Drug Evaluation and Research, told The New York Times on Saturday. Come on, anyone who witnessed an Ari Fletcher press conference knows P.R. rule number one: No matter what happens, it's always just business as usual.

In a tone that boarders on condescension, the FDA rejection letter painstakingly describes the requirements to develop a package and marketing approach that accommodates for the drug's distribution among different age groups, even calling the suggestion "novel." I suppose the FDA doesn't have much interaction with the ATF (Bureau of Alcohol, Tobacco and Firearms), who seems to be able to grasp such difficult concepts as age requirements for certain products.

But perhaps that's not fair. Those three things have been around for a lot longer than widely available, nonprescription birth control, though it seems the FDA believes that they are comparably dangerous. Instead, let's look at some instances where nonprescription drugs have been effectively regulated. In both Missouri and Tennessee, local and state legislators have passed laws limiting the amount of Sudafed that can be sold to a single customer in an effort to stop the production of crystal meth. Though the scourge of this new and deadly drug continues to ravage the heartland of America, hundreds of arrests involving the possession of large quantities of Sudafed have stopped thousands of meth labs before they started.

Similarly, in suburban areas where adolescents have begun abusing nonprescription cough medicine, neighborhood pharmacies have refused the sale of such drugs to customers under a certain age. And all this without any warning label on the box at all. The FDA should follow its own advice and approve Plan B for use by the general public. Labeling should be a secondary, logistical matter and not an issue that makes or breaks the development of legitimately and immensely useful research.

Although people may have more sex because of the morning-after pill, it should be up to them, not the FDA, to decide.

The government can contradict my ideals, but I hate it when it insults my intelligence. We see now why scientists often don't make good politicians; they simply aren't very good liars.