F.D.A. Rejection of Next-Day Pill

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Report Details F.D.A. Rejection of Next-Day Pill

Published: November 15, 2005
WASHINGTON, Nov. 14 - Top federal drug officials decided to reject an application to allow over-the-counter sales of the morning-after pill months before a government scientific review of the application was completed, according to accounts given to Congressional investigators.

The Government Accountability Office, a nonpartisan investigative arm of Congress, concluded in a report released Monday that the Food and Drug Administration's May 2004 rejection of the morning-after pill, or emergency contraceptive, application was unusual in several respects.

Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded.
Top agency officials were deeply involved in the decision, which was "very, very rare," a top F.D.A. review official told investigators. The officials' decision to ignore the recommendation of an independent advisory committee as well as the agency's own scientific review staff was unprecedented, the report found. And a top official's "novel" rationale for rejecting the application contradicted past agency practices, it concluded.The pill, called Plan B, is a flashpoint in the debate over abortion, in part because some abortion opponents consider the pill tantamount to ending a pregnancy. In scientific reviews, the F.D.A. has concluded that it is a contraceptive. The report suggested that it quickly became apparent that the agency was not going to follow its usual path when it came to the pill. "For example," it said, "F.D.A. review staff told us that they were told early in the review process that the decision would be made by high-level management."
Continued at:
http://www.nytimes.com/2005/11/15/politics/15pill.html?th&emc=th

The FDA makes a decision based upon politics not science. What is your opinion should this agency ever have it's decisions be influenced by political and partisan considerations?

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There is no science in this country anymore. We are all supposed to believe in "intelligent design". And that global warming is not caused by humans and does not cause hurricanes. We are also supposed to believe the Earth is only 10,000 years old. Welcome to the Christian Right America!

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Dear Lord,

Please protect me from the people who want to protect me from myself.

Amen

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*sigh* While I don't agree with the morning after pill, I agree with someone elses right to use it.

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Just one more reason to defeat the republicans and their religious zealot supporters in the next election. They are the enemy of freedom American's cherish.

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We've been through all this before. Back in the early 1990s Plan B, then known as RU-486, was approved for use and widely available by prescription in Europe. David Kessler, head of the FDA at the time, suspended review of the approval license for RU-486 as an imported prescription drug. The SC eventually ruled that the FDA decision was arbitrary and not based on medical science. We will probably need to go down the same road again, but the FDA, although it answers to Congress, has a charter it must follow.

Quote:

Benten v. Kessler: the RU 486 import case.

Pine RN.

PIP: On July 1, 1992, the case of Benten v. Kessler was filed in the US District Court in New York. The case arose out of an attempt by abortion rights activist Lawrence Lader to call public attention to the US Food and Drug Administration's (FDA) ban on importation of the abortifacient drug mifepristone known as RU-486. The ban expresses the anti abortion stance of the Reagan and Bush administrations and creates a hostile climate for the development of new drugs related to reproductive health and reproductive choice. Plaintiffs in the Benten case sought public accountability by the FDA for its adoption of a ban of a safe and effective drug for unwanted pregnancy. Although the case did not succeed in retrieving the confiscated RU-486 pills for Leona Benten, in its opinion issued on July 14, 1992, the New York district court judge concluded that the import ban did not appear to be based on concern with the safety or effectiveness of RU-486, describing the FDA's process of adopting the import ban as a sink of illegality. On July 17, 1992, 7 Justices of the Supreme Court, with justices Blackmun and Stevens dissenting, joined in a per curiam opinion denying the application and foreclosing further personal relief for Leona Benten. This was the best result possible short of an all out victory for Leona Benten. The Court ruled against plaintiffs in their argument that notice and comment were required, but left entirely open plaintiffs' claims that the import ban is arbitrary and capricious under the Administrative Procedure Act and that the ban is unconstitutional in that it unduly burdens the right to terminate pregnancy. This backdrop creates a healthy skepticism about the prospects for the introduction of RU-486 into the US in the near future as well as about the fairness of government processes in areas of concern to women. Public health considerations, not politics, should determine access to health care.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1434768&dopt=Abstract

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What is it about Plan B that you object to, Bella?

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boomerang wrote:

What is it about Plan B that you object to, Bella?

Ya know, I thought that there was something else in it but it is just really high doses of birth control, isn't it?

I have some moral objection to the pill too, even though I take it. It technically can be considered abortion because it prevents a fertilized egg from implantation and it is then flushed from the body.

On second consideration, I think that maybe it along with all birth control should be available otc because then it wouldn't be so expensive and/or hard for young girls (who are going to be having sex with or without the pill) to get. Perhaps, kept behind the pharmacy counter so that who ever buys it is told how to use it properly.

Yes, on second thought, I think that it should be otc.

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SO??
Whats your point?

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Who are you talking to, mysteryman?

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boomerang wrote:

Who are you talking to, mysteryman?

au.
Instead of getting the pill OTC,you need a prescription.
Whats the problem?

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Mysteryman, Plan B is considered a form of contraceptive. Why should a girl or woman go to her doctor every time she has intercourse. Plan B could theoretically replace BCP as the primary source of birth control among women. Why take something every day for contraception if one only has occasional sex?

I think Bella's behind the counter idea is a good one, particularly when it first becomes available, but I don't see why someone should get a prescription every time she has sex.

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mysteryman
There is no need for a prescription to purchase an aspirin, advil and etc. Why should one be required for this item? Since it been proven to be medically safe why should it be treated differently from any other item found on the drugstores shelves.
I am sure if the religious right had it's way a prescription would be needed to purchase condoms.

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Bella Dea wrote:

boomerang wrote:
What is it about Plan B that you object to, Bella?

Ya know, I thought that there was something else in it but it is just really high doses of birth control, isn't it?

I have some moral objection to the pill too, even though I take it. It technically can be considered abortion because it prevents a fertilized egg from implantation and it is then flushed from the body.

On second consideration, I think that maybe it along with all birth control should be available otc because then it wouldn't be so expensive and/or hard for young girls (who are going to be having sex with or without the pill) to get. Perhaps, kept behind the pharmacy counter so that who ever buys it is told how to use it properly.

How the morning after pill acts, I dunno. That may make implantation unlikely... and may qualify for some folks as abortifacient.

Yes, on second thought, I think that it should be otc.

Bella, it was my understanding that the IUD was considered by the Catholic church to be an abortifacient, that is, not letting a fertilized egg to implant.

Birth control pills' effects include having ovulation of the egg not occur, so there is no fertilized egg to "abort".

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Technically, you are right, however I was taught that the bcp is a form of abortion as well. Maybe it isn't now (I haven't been to church in years) but back when I was young, it was a huge no no.

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Bella, the Catholic Church used to teach that the purpose of intercourse was for procreation. Vatican II modified that to the extent that married couples could "enjoin" for the purpose of unity. Still, the primary purpose of coitus is pro-creation. Therefore, artificial birth control is prohibited.

Most American Catholic woman ignore this medieval doctrine and do it in good conscience. They are able to remain in the Church, receive the sacraments, etc.

I don't ever recall birth control being considered abortion.

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mysteryman wrote:

boomerang wrote:
Who are you talking to, mysteryman?

au.
Instead of getting the pill OTC,you need a prescription.
Whats the problem?

You are restricting my freedoms, that is the problem. Are you planning on using the morning after pill, MM?

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I have no dog in this fight and really don't care if it is OTC or by prescription. That said, I feel the need to point out to you Bluesgirl that requiring you to have a prescription for the morning after pill is not a restriction of your freedom. Many medications are required to have a prescription to obtain, so that in and of itself is not a restriction of your freedom. Rather, it is for your protection.

As to the validity of the FDA requiring a prescription, who knows? It may well be that requirement should be dropped. But from some of my reading about the morning after pill, there are enough medical issues to at least make the FDA cautious in making it an OTC item.

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The last Pope just insisted we control ourselves and don't use contraception. Yea right.

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I too have no dog in this fight. I object however the imposition of restrictions on an individuals personal freedom based on the wishes and beliefs of a religious sect.

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F.D.A. Rejection of Next-Day Pill

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