A Clear Voice: Murray & Clinton Plan to Hold Up FDA Chief Confirmation

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April 07, 2005

Murray & Clinton Plan to Hold Up FDA Chief Confirmation

Democratic Senators Patty Murray and Hillary Clinton said they would block confirmation of Lester Crawford as Food and Drug Administration chief because of delays in approving over-the-counter sales of Barr Pharmaceuticals Inc.'s Plan B [emergency] contraceptive. Murray said Crawford, who has been acting commissioner since March 2004, wouldn't pick a date for issuing a decision. The senators will hold up confirmation until there is a ruling on the filing, she said. The FDA didn't provide any new information during the meeting and isn't requesting any new information from the manufacturer, Murray said.

Plan B is an emergency contraceptive. It works differently than RU-486, which is an abortifacient Plan B prevents ovulation, prevent sperm from reaching the egg, and prevent implantation just like birth control pills do. It has no effect on a fetus.

Proponents, such as NOW, wish Plan B to become over the counter because since it must be taken within a few days to be effective, it would be easier to get without needing a prescription. However, I note that the manufacture’s drug insert says that it is not necessary to get a physical examination before being prescribed the drug. What’s the big deal about calling your doctor, asking for it, waiting for a little bit, and then going to the pharmacy?

I’ll tell you what the big deal is, it’s teenagers. NOW wants them to be able to get whatever contraception they want whenever they want without having to ask their parents permission. (They want the same for abortions too, for that matter.) However, as with this issue in regards to abortion, there are moral and health issues here. Personally I’m against abortion and for contraception. However, there are certainly parents who are morally against contraception. Should their parental rights be ignored? Plan B, while not having a lot of serious risks, does have risks. Since it is similar to progestin-only contraceptives that increase the risk of ectopic pregnancies, (which can be life-threatening) it is hypothesized that Plan B could also have similar risks, though there haven’t been studies done to confirm or disprove this hypothesis. (Again, I am getting this from the manufacture’s drug insert.) If a kid can’t ask her parents to take her to a doctor for a contraceptive, how will she be able to ask them to take her to the doctor for an ectopic pregnancy?

The first proposal to make Plan B over the counter had no age limits at all. This time the limitation that the purchaser must be over the age of 15 has been added. Are 16 year olds really that medically and morally responsible?

I find it odd that the FDA would be considering approval of an emergency contraceptive being released without a prescription, without approving the same for regular contraceptives. I suppose the idea would be that since it is supposed to be a one time thing, the patient doesn’t need to be monitored for long-term effects. But what’s to stop someone from taking them long term? The manufacture says that Plan B is not recommended for long term use, is not as effective as the Pill for long term use, and they haven’t even done studies on long term effects. And they want to hand these out like aspirin? At least we know the long term effects of aspirin, and some kid isn’t going to be afraid to tell their parents that they’ve been taking aspirin for 12 months when they need to go to the doctor for a stomach ulcer.

Despite my reservations on the subject, there’s been no reason to suspect the FDA of bringing conservative politics into this, and Crawford has said recently that the drug will probably be approved.

(Check out the Hillary Watch catagory for more stuff Hillary Clinton has been up to.)

"The science part is generally done," Crawford told Sen. Hillary Rodham Clinton, D-N.Y., who had pressed him on the issue. "We're just now down to what the label will look (like). This is going to be a very unusual sort of approval."
…

Sen. Patty Murray, D-Wash., also questioned Crawford aggressively, asking whether a formal decision on Plan B would be announced before the Senate Committee on Health, Education, Labor and Pensions votes on his nomination, probably April 13. Crawford said he doubted a decision would be forthcoming by then because of the application's complexity.

Sounds like Murray and Clinton are the ones bringing politics into this, not the FDA. Don't you just love all these Democrats abusing their power?

Posted by illuminaria at April 7, 2005 04:34 PM

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