The politics of birth control can produce unusual allies. Take Monday’s ruling in federal district court in New York, overturning the Food and Drug Administration’s ban on selling the morning after Plan B contraceptive over the counter to women younger than 18.
The judge in that case, Edward Korman, scathingly criticized several Health and Human Services and FDA officials for bowing to “pressure” from President George W. Bush’s White House and its “constituents,” and for using “political considerations, delays, and implausible justifications” to hold up nonprescription sales of the birth control drug for years.
In a 52-page ruling, Korman sounded like a speechwriter for President Barack Obama, accusing the FDA and the Bush administration of tossing science under the bus to “appease” conservative supporters of Bush in Congress and the Republican Party.
But Judge Korman is no leftover liberal from Bill Clinton’s era—he’s an appointee of Ronald Reagan, and long before that, was in the Justice Department under President Richard Nixon…
Meantime, if the Obama White House does not appeal the ruling, it will mark the fourth significant departure from the Bush administration’s positions on controversial health-care issues since Obama’s inauguration. The other three decisions allow federal funds for embryonic stem-cell research and for international aid groups that offer abortion counseling, and a move to lift the rule that would let medical personnel shun abortion-related services on the basis of their conscience.
Only controversial to nutballs who think we should live under a theocracy.
Bobbo, my point is that I think it is likely that this would become the primary contraception for many people, especially if provided over the counter without seeing a doctor, hence Plan A.
Again, Congress hasn’t passed a law saying Plan B should be allowed, they authorized a general process for drugs and medical devices. I have doubts as to the constitutionality of this delegation of authority, but we’ll ignore that.
The FDA’s review panel concluded that Plan B would not become ‘plan A’, and this was one of the points which caused the director to override the decision. It may have been that he would have overridden in any case for political reasons, but my point is that a review based on science alone would not reach such an opinion, which seems very illogical.
Without this scientific conclusion, Plan B could not have been accepted for OTC under the FDA review process. It could be that this science is based on corporate research which has a huge incentive to reach one conclusion, but that is also a ‘politcial’ decision.
#40–RBG==you fail by clearly stating how silly your rule is. No one, not even YOU when not caught in a blog would say Parents should be able to do whatever they want to/with their kids. Absent your clear REASONING for your position, it is as arbitrary to have a rule one way or the other.
My rule is based on recognizing that kiddies in a good relationship with their parents will involve them and that kiddies that feel the need NOT to involve them probably have good reason. Your posturing with no reason at all is sadly good enough for too many ill informed people who turn out to be bigots on so many other human dignity/freedom questions.
#41–Mike==we aren’t connecting with one another. Probably my lack of knowledge about “the political” aspects of the FDA. It just seems to me the political can and should be separated from the science of an issue. When they are not separated, that is a political insult JUST AS THE JUDGE FOUND HERE. Either the day after drug is “safe” or not. Seems like a scientific issue to me. Whether women should be allowed to use it before or after sex, or with or without prescription, or with or without parental notification seems political to me and not the purview of the FDA.
If someone sees a difference, and the other doesn’t, who most likely is correct?
#41, Lyin’ Mike,
The FDA process is to be beyond politics. That is why they do not cover tobacco, alcohol, or marijuana.
They are to be concerned with the science of a product, not the morality. If a product meets the requirements then it is to allowed into the market with the restrictions the science requires.
With “Plan B”, that review process was over ruled by the political process. The science said the drug was safe for all women. The science and the manufacturer agree that it is not as effective as other forms of prevention. It does, however, reach the standard set by FDA regulations to be sold, without a prescription to women 16 and older.
Should “Plan B” be the first line of prevention? No. Will it be? Yes, for some women. Is that a concern for the FDA? No, they are not and should not be concerned with morality. That is the basis for the Judges ruling.
>That is why they do not cover tobacco, alcohol, or marijuana.
Strangely enough, this is the one drug mentioned in the GAO report, Nicorette and similar products, covered by the FDA.
>Whether women should be allowed to use it …with or without prescription …seems political to me and not the purview of the FDA.
Think about that. Whether a drug is used without prescription should not be the purview of the FDA? I can see a libertarian argument for that, but I don’t think that’s what you have in mind. So, there is a safety issue evaluated by the scientists.
>Should “Plan B” be the first line of prevention? No. Will it be? Yes, for some women. Is that a concern for the FDA? No, they are not and should not be concerned with morality.
It is a concern for the FDA. Perhaps you don’t realize that there is a safety issue involved if Plan B is the primary form of birth control.
This was part of the review process. They concluded that Plan B would not be the first line of prevention if sold without prescription, that is without a doctor’s consultation. Without this conclusion, they likely could not have approved over the counter sale. This was one of the reasons given for the director’s override.
So for now Fusion is against the scientists’ opinion, but perhaps you change your mind given their finding.
#45, Lyin’ Mike,
Strangely enough, this is the one drug mentioned in the GAO report, Nicorette and similar products, covered by the FDA.
Nicotine is a drug that is covered by the FDA. Tobacco is a product exempt from the FDA and covered under (I believe) 12 different Acts.
#46–Fusion==”>Whether women should be allowed to use it …with or without prescription …seems political to me and not the purview of the FDA.” /// Correct. Can’t keep track of the context or what? If the drug is NOT SAFE, it is not put on the market even if people want it. If it is safe, then the political BS starts.
There is no way you should be confused by this.
# 46, Stooopid Lyin’ Mike,
It would be so much easier if you could let us know who you are quoting.
Think about that. Whether a drug is used without prescription should not be the purview of the FDA?
The FDA did think about it. Very hard too. Their scientific review panels and committees came to the conclusion it was safe enough to be sold over the counter. The question was whether 16 y/o would be allowed to buy it without a parents permission.
Perhaps you don’t realize that there is a safety issue involved if Plan B is the primary form of birth control. This was part of the review process.
Yes it was. The morality of whether or not a woman will use regular birth control was not the issue. Women are free to choose if they even want to use birth control and what type. Some women can’t handle the side effects of the various birth controls and so yes, this could be their primary choice. Other women might have second thoughts about the father.
All the FDA can do is see if the product is a safety risk if used as directed. The scientists at the FDA decided it wasn’t. “Plan B” is in the same class of safety as ibuprofen, acetaminophen, and tampons. Used as directed they are very beneficial. If they are misused, the results can be quite serious.
So for now Fusion is against the scientists’ opinion, but perhaps you change your mind given their finding.
So Stooopid Lyin’ Mike is still making shit up as he goes.
>The question was whether 16 y/o would be allowed to buy it without a parents permission.
No the question was whether a 16 y/o would be allowed to buy it without prescription, without doctor’s consultation.
There is a safety issue involved if not having the doctor’s consultation would lead to unsafe use.
>All the FDA can do is see if the product is a safety risk if used as directed.
That’s not the only thing the FDA does. They also decide the likelihood of something being used as directed, whether a prescription is required so that a doctor’s consultation will make things more likely to be used as directed, etc.
You said:
>Should “Plan B” be the first line of prevention? No. Will it be? Yes, for some women.
Well the FDA scientists disagree with you on this very point.
I’m getting all this from the GAO review of the FDA review. I think it’s this one.
http://www.gao.gov/htext/d06109.html
>If the drug is NOT SAFE, it is not put on the market even if people want it. If it is safe, then the political BS starts.
That’s not how it works at all. Most drugs on the market are unsafe if misused, including over the counter drugs. So there is some level of safety that has to be agreed upon, and this is also in some cases political. Here the safety issue is because of possible misuse.
Basic point is that the drug is safe as secondary birth control, but not as repeated use as a primary birth control, or something like that.
The question is if it’s sold without prescription, without consulting a doctor, how likely is it to be used as a primary form of birth control?
If the answer is likely, then it is reasonable to have it be required by prescription only.
Here the question was for children vs adults, and the prescription is only required for children.
#51–Mickey==when you are digging in a pile of horseshit, STOP!!
“Most drugs on the market are unsafe if misused.” /// NO. Anything, drugs or anything, on the market or not, are unsafe if misused.
Too stupid to respond to except as already done.
Bobbo, you have already said you are unclear on the FDA process. I skimmed thru the GAO report and am trying to explain it to you. The safety of a drug gets evaluated in context of how it is used.
So your statement of
>If the drug is NOT SAFE, it is not put on the market even if people want it.
makes no sense, given that anything can be unsafe. A drug gets put on the market based on certain evaluation.
In this case one of the evaluations was whether Plan B would be a primary form of birth control, or used as intended.
If your child doesn’t confide in you and trust you to help them with problems by the time they are 16, you already blew your parenting opportunity. The argument that this abrogates parental authority is disingenuous. Also, if you don’t know enough about your childs activities after 16 years to at least be aware that they have a problem, you don’t deserve to be part of the solution.
Stooopid Lyin’ Mike,
one of the evaluations was whether Plan B would be a primary form of birth control, or used as intended.
“Plan B” is intended as a back up plan in case the primary birth control doesn’t work (ie, hole in condom) or there is no primary birth control (as in unexpected sex or rape). The reason is the efficacy is not as good as most other forms of birth control. It is, however, better than nothing and for those who have very sporadic sexual encounters, this might end up being a more suitable alternative than no protection at all.
I’m sure the FDA will not suggest ibuprofen will cure a broken leg, but it can be better than nothing when nothing else is available. The anti-inflammatory and pain relieving properties of ibuprofen can help the patient. But no one in their right mind is going to suggest this is all a person SHOULD do.
#54, Alix,
You make a good point but I don’t totally agree. Even a 16 y/o has secrets they won’t tell their best friend. That doesn’t mean they don’t trust their parents or friends, but the embarrassment is just too much.
For example, while normal people, and by that I mean you and I, would sure the heck want to know if an extended family member forced our daughters to have sex, it is quite possible the daughter wouldn’t want to tell us.
42 bobbo No one, not even YOU when not caught in a blog would say Parents should be able to do whatever they want to/with their kids.
You’re right. Except for 99.9999% of parents. Keep your hands off them and their innate rights and responsibilities and I’ll sign on. Figure some other way to take care of the problematic cases where the parents are some kind of monsters.
RBG
#55, you write so much yet understand so little
Your own statement has you contradicting the scientists. Have you changed your mind about that? I think you are right, and the scientists are wrong.
Will Plan B be used as a primary form of birth control?
#58, Stooopid Lyin’ Mike,
Will Plan B be used as a primary form of birth control?
As I have already written, YES. Is that the smartest thing to do? NO. Are there reasons a woman might prefer to use “Plan B” as her primary source of protection? YES.
People take and abuse* OTCs every day. Occasionally they cause injury. Usually not. But used as intended, all OTCs have a large safety factor and can tolerate most abuse.
*= using other than as directed or intended on the package.
#57–RBG==no, YOU figure out some other way. The law IS the solution to the problem. Throwing it out without even a suggestion of something else is irresponsible.
We’ve had 8 years of that. Time for change!!