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» Scarleteen Boards: 2000 - 2014 (Archive) » SCARLETEEN CENTRAL » Sexual Ethics and Politics » Did the FDA pass remedial math?

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Author Topic: Did the FDA pass remedial math?
Heather
Executive Director & Founder
Member # 3

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From Kaiser today:

quote:
In The Courts | FDA Attorneys Seek Dismissal of Plan B Lawsuit; CRR Lawyers Seek Subpoenas for White House Documents, Testimony
[Oct 12, 2006]
The Center for Reproductive Rights on Wednesday during two hearings at a U.S. District Court in New York City asked federal judges to grant a subpoena of White House documents and officials in its lawsuit against FDA over the agency's rejection of Barr Laboratories' first application for nonprescription Plan B sales, Long Island Newsday reports (Kerr, Long Island Newsday, 10/12). CRR on behalf of the Association of Reproductive Health Professionals, the National Latina Institute for Reproductive Health and others filed the suit claiming FDA did not follow procedure when in May 2004 the agency sent a "not approvable" letter in response to an application originally submitted by pharmaceutical company Women's Capital for nonprescription sales of Plan B. Plan B can prevent pregnancy if taken up to 72 hours after sexual intercourse. Women's Capital later was purchased by Barr. FDA in the "not approvable" letter cited inadequate data on Plan B's use among girls younger than age 16, and Barr subsequently submitted a revised application to make the drug available without a prescription only to girls and women ages 16 and older. In a July 31 letter to Barr subsidiary Duramed Research, acting FDA Commissioner Andrew von Eschenbach wrote that 18 is the "appropriate age" to allow women to buy Plan B without a prescription and asked Barr to raise the age restriction in its application from 16 to 18. Barr in August resubmitted its application and FDA approved it later that month (Kaiser Daily Women's Health Policy Report, 8/25).

Hearings
Franklin Amanat, an assistant U.S. attorney representing FDA, on Wednesday said FDA plans to file a motion for dismissal now that the "vast majority who would purchase the drug" without a prescription may do so. However, federal Magistrate Viktor Pohorelsky, who is hearing arguments in the lawsuit, said, "I'm inclined to permit discovery [in the case] be completed," adding, "How much, I don't know." CRR is seeking subpoenas for testimony from former White House policy aide Jay Lefkowitz and FDA Deputy Director Sandra Kweder (Driver, Reuters, 10/11). CRR attorney Simon Heller said if the government has "nothing to hide, they shouldn't be fighting it" (Long Island Newsday, 10/12). Amanat said CRR has not produced evidence required to force presidential records to be released (Caruso, AP/SiLive.com, 10/11). U.S. District Judge Edward Korman during a hearing in the case earlier in the day said that the FDA's rejection and delays of Barr's application "reeks with bad faith" (Long Island Newsday, 10/12).

You know, I'm no math expert, but I don't think it takes one to figure out that actually, NO, the vast majority of those who need/would use EC do NOT have access.

Let's say that we accept 50 as the average age of menopause, a typical age listed. Few women over 50 need EC.

Let's say we take 11 as the average age of first menstruation/ovulation, meaning, at what age a woman is physically capable of becoming pregnant, another age typically and widely listed.

That means those who need EC, in general, are between the ages of 11 and 50. Even if 11 year olds, on average, aren't choosing to have sex, we also know that rape rates tend to be highest in the younger women, and that the youngest women of reproductive age are more likely to be coerced into sex, not to mention that some young women ARE choosing to be sexually active at a very young age.

So, we are looking at a span of 39 years, the lower end of which would far less often choose to become or remain pregnan; the lower end of which more often do not have the means to manage a pregnancy, no matter what choice they make.

Even if that were NOT the case (which would skew the numbers some, putting greater value on the lower end), if only those over 18 can get EC (which is still a joke, since pharmacist refusals are a very big and pervasive issue, likely to become more so once Plan B is over the counter), then only 31 of those years are covered, or barely 75%, if I'm not off. A majority? Yes, for sure. But a vast one, especially when we take into account the factor of which women are in the best, and which the worst, to manage a pregnancy, to have pre-natal care or abortion available to them? To have a pregnancy NOT put their health and aspects of their lives in big jeapordy? Vast, my aunt fanny.

(And no, to my understanding studies have not been done on 11-year-olds using EC, but we do know, no matter what, it's less harmful than pregnancy is for a woman that age. However, we have plenty of over-the-counter medications which pose dangers to younger people which are totally accessible to them. As well, the arguments from the FDA about 18 as the age have NOT cited concerns about young women's health: it has been stated this age was chosen to make it "easier" for sellers to remember since it is the same age as required to purchase cigarettes.)

So hey: many of you are under 18. What are you doing to lobby for the right to OTC Plan B for yourself and your peers? Do you think this lawsuit should be dismissed, especially given how much evidence we have that the FDA has NOT, throughout this whole saga making Plan B OTC over the years, acted in the manner in which the agency is supposed to, is required to, per being concerned with HEALTH issues, bot with iossues of politic or policy?

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Heather Corinna, Executive Director & Founder, Scarleteen
About Me Get our book!
Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has. - Margaret Mead

Posts: 68290 | From: An island near Seattle | Registered: May 2000  |  IP: Logged | Report this post to a Moderator
Djuna
Activist
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Well, I think I'd have a hard time organising a protest in the UK, seeing as it's US legislation [Big Grin] , but if anyone's signed an online petition in this vein I'd be grateful if they could point me towards it.

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In a strange room, before you are emptied for sleep, what are you. And when you are filled with sleep you never were. I dont know what I am. I dont know if I am or not... how often have I lain beneath rain on a strange roof, thinking of home.

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not_a_hobgoblin
Activist
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I've talked to a lot of friends, about it, and generally tried to raise awareness, but I'm not sure what else I can do to help. Where should I send letters? Congressmen? Senators? Directors of the FDA? I'm willing to get a writing campaign going in my area if I have a useful idea of where to point it.

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"Cut her down."
"She is a witch!"
"But she's our witch. Cut her down."

Posts: 174 | From: Indiana, USA | Registered: Jun 2006  |  IP: Logged | Report this post to a Moderator
Heather
Executive Director & Founder
Member # 3

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I'd suggest starting local: your state pharmacy board, your state representatives, your governor.

Also sending a letter to the head of the FDA is a great idea, or just copying him on the letters you send to the pharmacy board and your reps.

--------------------
Heather Corinna, Executive Director & Founder, Scarleteen
About Me Get our book!
Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has. - Margaret Mead

Posts: 68290 | From: An island near Seattle | Registered: May 2000  |  IP: Logged | Report this post to a Moderator
Rumored
Neophyte
Member # 27901

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I just found this and thought it was relevant to anyone who wanted to help:

http://www.emergencykindness.net/

There aren't many blocks to access in my area, but I think when I get some money I might get some EC and see if I can get it to someone in overnight mail.

Posts: 33 | From: California | Registered: Mar 2006  |  IP: Logged | Report this post to a Moderator
   

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