iPledge Restrictions Eased

Hot on the heels of the resounding success of iPledge, the $100 million program intended to insure that Accutane users don't get pregnant while on the drug, the FDA has decided to ease restrictions on access to the drug:

A program called iPledge was designed to ensure that every user of Accutane or its generic competitors — and every doctor who prescribes it and every pharmacy that sells it — follows strict rules to make sure that women don't get pregnant while on the drug. Among those rules are month-by-month prescriptions based on passing pregnancy tests.

But last summer, the Food and Drug Administration heard evidence that iPledge hasn't ended the problem: There were 122 pregnancies in the program's first year and another 37 in the four months since. Another 19 pregnancies occurred in women who managed to get the drug despite never enrolling in iPledge.

Still, in October the FDA agreed to a few changes to the program, and announced Wednesday that iPledge is now implementing these changes:

_Women of childbearing age who don't fill a prescription within seven days of a pregnancy test will be allowed to get another test and then fill the prescription — with the exception of the initial prescription. Until now, those who didn't act within seven days were frozen out of the program for the next 23 days.

_Those women will have to fill the prescription within seven days of a pregnancy test rather than within seven days of first seeing their doctor.

Evaluating The Program Designed To Prevent Pregnancies Among Accutane Users

Last year the FDA decreed that reproductive age women, in consultation with their physicians, are incapable of using Accutane, an acne drug, properly.

In order to protect women from themselves the FDA decided to only allow these women to receive proper care if they sign their life away 1) register their personal medical information with the government, and 2) submit to pregnancy tests. [Accutane is contraindicated in pregnancy.]

So the FDA paid a lot of money to a private company to enroll patients in a program (iPledge) designed to prevent pregnancies from happening in those patients.

It's now over a year later, and the results are in. Let's see how well 100 million dollars of your tax money protect women from themselves:

• 122 pregnancies reported in the program's first year.

[That's about the same as the number reported annually before the FDA tightened restrictions on the drug.]

• Another 37 pregnancies in the four months since.

• An additional 19 pregnancies in women who took the drug despite never enrolling in iPledge.

• Just 10% of the 122 women who conceived while taking the drug provided the detailed, follow-up information needed by the FDA to improve the program.

Faced with these stellar results of the iPledge program, the sage advisers to the FDA learn a lesson and decide that minor changes would ease access to Accutane and its generic competitors without further increasing those troubling pregnancies.

Not to be outdone, I also learn a lesson: I must get into this protecting-women-from-themselves racket. Not only is it lavishly funded--$100 million in Accutane protection here, half a billion or so in abstinence-only "education" there--but there is no expectation of, you know, actual results. If that's not the absolute cherry on top of the yummy cake of treating women like utter morons and getting paid for it I don't know what is.

Seriously, I can be as incompetent and patronizing as the next government subsidized person out there. So, if you have any ideas on ways to protect women from their very own selves feel free to send them my way.