Dback Jon

Uh Russ - hear of Plan B? Directly affected by politics.

Politics SHOULD NOT be a part of the FDA, but under the Bush Administration, politics has taken precedence over science.

__________________



R.I.P Tim Minnick

The KING of Cards

AzCards21

I refuse to acknowledge something that isn't true. You like to paint those that voted Bush into office as radical religious zealots and I'm telling you it's not true. Are there a few things that Bush let religion get in the way? Sure there are. Stem cells not being allowed to progress pissed me off. The number of Repubs that I know personally that jumped for joy at delaying the scientific advances of stem cells? None.

You have some grand vision of a republican religious army running the potus from a pulpit on every issue. I think you'd be surprised at the true pulse of who we are.

Put down the paint roller, it's only a tooth pick.

AzCards21

GEEZUZ H CHRIST!!!!

Post something to verify this happened or shut up about it!!!!

Dback Jon

you can start by reading the Minority Report on Bush and Science from 2003:

http://democrats.reform.house.gov/fe...cience_rep.pdf

(Yes, this is the Democratic Report, but they have numerous citations/proof)

Or maybe check out this from the Union of Concerned Scientists about the FDA....
http://www.ucsusa.org/scientific_int...st-survey.html

Maybe you will trust the GAO, talking about the Bush Admin's unprecedented decision to not approve (before the reversal last week) of Plan B:

http://www.gao.gov/new.items/d06109.pdf

This article gives more details on the 60 Nobel Science Lauretes that protested the Bush Admin's interference into science:

http://chronicle.com/free/v50/i26/26a01801.htm

__________________



R.I.P Tim Minnick

The KING of Cards

AzCards21

Now you're just trying to piss me off.

Find me a goddam article that shows where this vaccine was held up. This is where the arguement started and you aren't going to get away with some special commitees 200 freakin page Bush doesn't like science bull**** from 2003.

If you can't do it just say so.

nidan

Actaully no I wouldn't be, I been close to that in profesional life a couple of times myself.

In this case unfortunatly it appears to be true. Proving it to be true would, I suspect, be very tough. However every rumour I have heard suggests it was the GW's religious agenda that has kept this drug off the market until now.

Given the vitriolic denunciatations I have heard in the last few days from the religious right, are you suggesting that with their access to GW and the GOP, they didn't try to get the stopped ? That hardly seems credible given how much they seem to hate it.

I heard one today exposing how this becoming available it the same as saying 'it's ok to have unprotected sex to all women and girls'. Are you suggesting that folks like this didn't try to block this ?

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DogTv

nidan

No it wasn't a army of religious zelots that voted GW in.

However the social conservatives have effectivly hijacked the GOP primary system to the point where in most locations bowing to the religious conservative agenda is required to pass the primary. Second these folks did tip the balance for GW and that includes a certain religious zelot in Fl that got him into office in the first place, her agenda is becoming cleared every day.

GW is doing everything he can to blur the lines between church and state and to inject religion into policy making. Gay marriage is an obvious example and still you folks suppoort him, what else am I to think ?

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DogTv

nidan

Do you think they are stupid enough to make it so obvious as to be easily traceable ?

Look, every religious conservative I have heard on the radio since this was approved is livid about it. They hate the whole idea.

Are you suggesting that given the access that they have to GW [he is a religious conservative] that they wouldn't have tried to block it ?

__________________

DogTv

Divide Et Impera

Why are so many people so quick and willing to give the government the right to define relationships? If that isn't a blatant attack on Civil Rights, I don't know what is....

__________________
Quintus: People should know when they are conquered.

Maximus: Would you, Quintus? Would I?

AzCards21

Oh right, I forgot that the dumbest president in the history of the US has the ability to put together such grand schemes of sabotage. And really he's doing it just for that .1% that are willing to sacrifice their childs health over getting laid a few times.

Im going to say this one more time. You are painting all religious and right wing people with much too wide a swath.

Russ Smith

Maybe I'm out of the loop on that one but I thought the issue was they wanted it approved as OTC not prescription and the FDA ruled they simply filed to change that too late in the process and hadn't adequately proved it was safe for use without a prescription?

It was later approved(last week).

Maybe that was political but I just read the FDA's own explanation and it was pretty clear, there was insufficient data initially to support the claim that it was safe for use, especially by young people, without advice from a doctor. When they answered that question, it got approval.

__________________
“Your expectations always exceed outside expectations. I feel like you just can’t stop working, can’t stop getting better, because I’ll be a failure in my eyes before I’m a failure in someone else’s eyes.” -- Arron Afflalo

Dback Jon

No - it was recommended for OTC by the advisory panel, and by the FDA staff. Bush's old head of the FDA blocked the approval. The FDA only approved it for OTC after Senators put a hold on the new FDA's head nomination.

__________________



R.I.P Tim Minnick

The KING of Cards

nidan

Actually no I'm not but I can see you are hyperventilating about it.

I actaully think that most folks who go to church are reasonable people, Redstorm certinly is. I also don't think that the majority of these are evangelical fundementalists.

My point which you are missing is that what I don't see is the bulk of the 'reasonable' types standing up to be counted in controling the fanatics.

It seems like many of the more moderate types are content to let the fanatics run tings certainly on the national stage. You have sympathy for their position on Gay marriage, abortion, evolution, school prayer etc, so you let the more exteme positions slide by. That way you feel you will get a few of these religious changes encoded into law and to you that can't be bad.

I don't see concern for Jon's rights, I don't see concern for womens rights and I certinaly don't see concern for mixing or religion into science policy.

I'm not suggesting that you or many here [with an obvious exception to our resident right wing extremist] would push all of the these issues or push them as hard as some in DC are doing, but you won't vote out the folks that do, ergo you are tacitly supporting them.

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DogTv

Russ Smith

I guess I'm out of the loop. Here's what the FDA"s site says on it: Is Galson the ex FDA head you mention?



4. What steps did FDA take in considering switching Plan B from prescription to nonprescription (over-the-counter (OTC)) status?

FDA received an application to switch Plan B from prescription to nonprescription status. FDA staff reviewed the scientific data contained in the application which included among other data, an actual use study and a label comprehension study.

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.

5. Why didn’t FDA follow the recommendation of the Advisory Committees?

The recommendations of FDA advisory committees are advisory in nature and the Agency is not bound to follow their recommendations. FDA makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee.

6. Why did FDA issue a Not Approvable letter?

The agency issued a Not Approvable letter because the supplemental application did not meet the criteria for approval in that it did not demonstrate that Plan B could be used safely by young adolescent women for emergency contraception without the professional supervision of a licensed practitioner. The issuance of a Not Approvable letter does not mean that a supplemental application cannot be approved. The Not Approvable letter describes what the applicant would need to do to obtain approval for the supplemental application. In this case, the applicant would have to either provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug or provide additional support for the revised indication to allow for marketing Plan B as prescription-only for women under the age of 16 and as nonprescription for women 16 years of age and older. Not Approvable Letter.

7. Was there a difference of opinion within the Center for Drug Evaluation (CDER) and Research regarding the final decision?

Yes, there was a difference of opinion within CDER. The scientific interchange of ideas is widely encouraged during the review process to ensure a thorough vetting of the issues. However, ultimately, a final decision must be made based on the evaluation of the data, taking into account all of the views expressed.

8. Is this FDA’s final decision regarding the availability of Plan B for OTC use?

No. The Not Approvable letter to the sponsor outlines what the sponsor must do to obtain approval of the supplemental application.

Wide availability of safe and effective contraceptives is important to public health. We look forward to working with the sponsor if they decide to pursue making this product available without a prescription.

9. Oral contraceptives have been used for four decades, and this product has been approved and used safely since 1999. How could FDA turn it down?

Oral contraceptives as a class of drugs are only available by prescription. This product has been used safely by prescription only and for the reasons already stated, it is not being made available for OTC use at this time.

10. The sponsor has talked about making the product over-the-counter for young women over a certain age and behind-the-counter for younger girls. Is there evidence to support such a scheme? Does FDA have the authority to carry it out?

The sponsor has submitted a plan and the FDA is examining its regulatory authority to approve a product marketed in this manner.

11. Did the FDA bow to political pressure in making this decision?

No. This decision was made within the Center for Drug Evaluation and Research.

12. Dr. Steven Galson signed the letter FDA sent to the sponsor. Does Dr. Galson usually sign such letters? Why did Dr. Galson sign the letter?

No, Dr. Galson does not usually sign regulatory action letters. However, his opinion of the adequacy of the data in young adolescents differed from that of the review staff. He believes that additional data are needed and for that reason he made the decision to take final action within the Office of the Center Director.

__________________
“Your expectations always exceed outside expectations. I feel like you just can’t stop working, can’t stop getting better, because I’ll be a failure in my eyes before I’m a failure in someone else’s eyes.” -- Arron Afflalo

Divide Et Impera

Which one?!?!?!?

__________________
Quintus: People should know when they are conquered.

Maximus: Would you, Quintus? Would I?