Sunday WaPo Story on Abortion

It is extremely sad. The FDA is playing politics with the drug approval process. They are dragging out the approval of a medication for no reason other than the fact that the conservative right has an issue with the drug and it would give the President another black eye. Politics should not play a role in determining which drugs the FDA greenlights.

Drugs are not just drugs when they involve human life. We shouldn't just be holding up its approval, but rather we should ban it outright.

As for that lady, there are consequences to actions. This couple made a choice to have unprotected sex, and I realize that she should only be expected to be so smart with 7 years of education (at least) and the fact that we as a species have only been reproducing for so long; but sometimes, there is no magic bullet to fix every thing we do that we then regret.

I feel no sympathy as this is not the story of some desperate, destitute woman. The end of the article stated that she is a lawyer which suggests that she is of some means, and therefore, her husband could have gotten a vasectomy which would have allowed them to have all the consequence free sex they wanted. Rather than welcome her baby into the world, she killed it.

What is the greater travesty is that a couple would reject the presence of another child simply based on their own selfish desires. That's what people like her are: selfish.

Riiiight…

Some lady forgot to use contraception (was that Bush’s fault?), had sex (was that Bush’s fault?), and then didn’t really feel like calling around to find a doctor offering the morning after pill (was that Bush’s fault?). This has nothing to do with the FDA and everything to do with some lady’s unbelievable selfish anger that led to the death of her 3rd child. Absolutely disgusting. To argue that Dana’s laziness and selfishness falls upon any federal agency is preposterous. She willfully engaged in unprotected sex and then wasn’t willing to call more than one doctor in an attempt to obtain Plan B… thus she should get ZERO sympathy for having to go thorough some sort of emotional difficulty when she had her unborn child killed because he/she was inconvenient and Dana was irresponsible.

Plan B is not being delayed due to senseless “politics”... it is available NOW with a simple prescription. Something Dina wasn’t willing to go out and get. I can’t believe you don’t see the horrible selfishness of Dina’s actions but are all up in arms due to the FDA’s legitimate concern with making Plan B available to minors over-the-counter (i.e. without any medical oversight).

Yes, Plan B is available now with a perscription, so long as you find a doctor willing to give you the perscription.

The FDA's concerns over providing the drug over the counter to minors is political in nature and not medical in nature. I.e. providing birth control alternatives over the counter would increase the likelyhood of children having sex. Ignoring the fact that children will have sex regarldess of whether or not birth control is available to them.

Should we offer the regular birth control pill over the counter as well Craig?

I think (per your logic) everyone in America who got pregnant because they failed to use contraception should just blame the FDA for being "political"... shame on them! Expecting some semblance of personal responsibility and accountability!

There is a difference between Plan B and regular birth control pills. Regular birth control pills have a much higher risk of side effects and require consultation to make sure that the individual taking them get the right pill for their personal medical needs. If there was a one size fits all birth control pill then yes, absolutely it should be offered over the counter. Many perscription medications have become over the counter drugs when they were proven to be safe in that context.

Having options available to people so that they can make choices is responsible. Denying choice for political reasons is irresponsible. The FDA's mandate is to decide on the safety of medication devoid of its political ramifications.

This decision was made within the Center for Drug Evaluation and Research... not some un-scientific political entity. They found the following:

"On December 16, 2003, we held a public advisory committee meeting with a panel of medical and scientific experts from outside the federal government. The members of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health, met jointly to consider the safety and effectiveness data of nonprescription use of Plan B. Although the joint committee recommended to FDA that this product be sold without a prescription, some members of the committee, including the Chair, raised questions concerning whether the actual use data were generalizable to the overall population of nonprescription users, chiefly because of inadequate sampling of younger age groups.

Following the advisory committee meeting, FDA requested additional information from the sponsor pertaining to adolescent use. The sponsor submitted this additional information to FDA in support of their pending application to change Plan B from a prescription to an over-the-counter product. This additional information was extensive enough to qualify as a major amendment to the NDA. Under the terms of the Prescription Drug User Fee Act (PDUFA) performance goals, major amendments such as this may trigger a 90-day extension of the original PDUFA deadline.

Now FDA has completed its review of the supplemental application and concluded that the application could not be approved at this time because 1) adequate data were not provided to support a conclusion that young adolescent women can safely use Plan B for emergency contraception without the professional supervision of a licensed practitioner and 2) a proposal from the sponsor to change the requested indication to allow for marketing of Plan B as a prescription-only product for women under 16 years of age and a nonprescription product for women 16 years and older was incomplete and inadequate for a full review. Therefore, FDA concluded that the application was not approvable."

Doesn't sound like a bunch of BS to me. Given the fact that women are dying taking RU-486 I'd appreciate our federal drug agency using some caution before approving any drug.

But we digress. This is a particularly absurd situation where a selfish lawyer willfully engaged in unprotected sex and was too lazy to call more than one doctor to obtain Plan B... and then she kills her unborn child and blames it on Bush. Absolutely ridiculous. This is not the result of some "political" decision of the FDA... it is the result of a arrogant and selfish woman who doesn't believe in personal responsibility.

Craig, the reason you give for the failure is that of those who want the drug OTC. The official response is that the medical safety of the medication has not been satisfactorily proven for children, and the submission which suggested a dual-track was incomplete and could not be considered.

They may be lying, but I just wanted to point out that what you assert as a fact is actually a point of contention.

The fact is that the FDA has not approved the drug for OTC, and at this time doctors in Virginia don't have to prescribe medication if they don't want to.

I'll make one point, but no more, because this is a topic I've been working on -- the woman spent a lot more time looking for, finding, and going to an abortion doctor, than she did trying to get the pill she said would have prevented her from having to make "the hard choice". She went to Planned Parenthood in DC on a Saturday -- surely she could have gone to Planned Parenthood in Virginia on a saturday to get the prescription.