Agency overrules FDA, says no to teens getting morning-after pill without prescription

[Freddie Stubbs]

Source: Associated Press

WASHINGTON (AP) – The U.S. Department of Health and Human Services overrules the Food and Drug Administration, saying no to younger teens having access to the morning-after pill without a prescription.

Teva Pharmaceuticals wants its Plan B morning-after pill to become the first truly over-the-counter form of emergency contraception. The pill can prevent pregnancy if taken soon after unprotected sex. Currently, women 17 and older can buy it without a prescription if they show a pharmacist proof of age. Younger teens need a prescription.

Doctors' and women's health groups have long argued that the pill is safe even for younger teens and that lifting the age restriction would increase access for everyone. The nearly decade-long over-the-counter push even wound up in federal court, where a judge in 2009 ordered the Food and Drug Administration to consider lifting the age limit.

Teva formally made that request for its Plan B One-Step in February, and the FDA's deadline to decide is Wednesday. If the FDA agrees, Plan B One-Step could be moved from behind the counter to sell on drugstore shelves.

Read more: http://yourlife.usatoday.com/health/healthcare/story/2011-12-07/FDA-debates-over-the-counter-morning-after-pill/51699388/1

[Lance_Boyle]

1. Um, Kathleen? That shit ain't cool. Fix it. n/t

[Freddie Stubbs]

10. Do you think that she made this decision without consulting her boss?

[Lance_Boyle]

11. I would assume so, yes.

That's why the President appoints a Secretary for each cabinet-level office - so he doesn't have to be consulted on every decision those offices must make. It would be very strange for a President to delegate authority in this way and then micromanage.

[HereSince1628]

2. Well, if insurance co.s and employers want to include grandchildren

on family policies, and if the courts will recognize grandparental financial obligations to the care and up-bringing of grandchildren I suppose that Grandparents authority to impose reproductive claims on their daughters' uteri is something that we might talk about.

[closeupready]

35. Why would we talk about abridging a woman's total authority on reproductive choice?

??

[saras]

3. So they have a plan to release emergency prescriptions on a couple hours notice?

[Ruby the Liberal]

4. Morning after vs 'The Doctor can see you in 3 weeks'?

[Shoe Horn]

6. ...good point. nt

[glinda]

25. I got it illegally in the early-mid 70's. Desperation will seek it out I hate to say. Scary.

[DreamSmoker]

5. Religious right again..

I am a Christian who is sick of those Radical Religious Nuts who are so Outspokenly Ignorant and righteous about it..
This group of Americans have kept America Down over and over again..
Its their way of the Highway 100% of the time..
Basking in their Righteous Ignorance as they persecute all others..

Since the Pilgrims to the Puritans..
These Folks were never ever for Freedom for all..
Just them..
The rest will can to hell..

Here it is again.. That influence in today's Article..
It has absolutely nothing to do with religious belief..
It pure Fear..
These Christian Folks only want freedom for the few..

Now with those Folks are so deep into the Federal Government..
They are still scared and insecure...
Still want things their way or the highway today..

The Abortion issue has been their pet for a very long time now too..
This article proves my point well..
This decision by The U.S. Department of Health and Human Services was based on this influence and not the Doctors or the Patients..

[leftyohiolib]

8. that's quite a rant over a whole lotta stuff that wasnt in the article

[atreides1]

14. Isn't Obama supposed to have a meeting

With the USCCB(Catholic Bishops) about the birth control guarantees in the health care bill...perhaps this is as another thread has called it the red meat being thrown to the USCCB...

Granted none of this is in the article, but knowledge of the meeting has been out there for some time now.

[Freddie Stubbs]

15. He already met with them:

http://www.usccb.org/news/2011/statement-on-meeting-archbishop-dolan-president-obama.cfm

[Name removed]

13. Deleted message

Message removed by moderator. Click here to review the message board rules.

[Shoe Horn]

7. I think they should lower the age...

...for many things.

Voting, drinking, control over your own body.
But not by much, maybe 15 or 16? I dunno.

Depends.

[thesquanderer]

9. Like Bush, Obama administration overruled FDA recommendation on this (N/T)

[ProSense]

12. A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius

A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius

Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.

In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.

FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.

The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.

The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.

Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc..

Letter to FDA Commissioner.

[suffragette]

21. Contrast with Statement from FDA Commissioner Margaret Hamburg, M.D.

http://www.democraticunderground.com/discuss/duboard.php?az=post&forum=102&topic_id=5082994&mesg_id=5083259

Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step

Date: December 7, 2011

The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.

Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse. The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17. In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence. The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process. Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs. CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

[ieoeja]

31. A summary of the difference:

"I do not believe that Teva's application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use."

"CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential."


In addition, the politician relied solely on Teva's application. While the FDA relied on independant research which the politician does not deem important enough to even mention in her letter.

Politicians overruling the scientific experts without citing any reason for ignoring the science should be impeached and removed from office. She is guilty of incompetence and an abuse of power.

[suffragette]

33. Exactly. It's a political overruling of science experts and it is completely inappropriate

Also, THIS is the area in which Sebelius chooses to create precedent by being the first health secretary to publicly overrule the FDA's science based decision:

http://www.nytimes.com/2011/12/08/health/policy/sebelius-overrules-fda-on-freer-sale-of-emergency-contraceptives.html?_r=1

Although Ms. Sebelius had the legal authority to overrule the F.D.A., no health secretary had ever publicly done so, an F.D.A. spokeswoman said.

From the same article, Susan Wood points out the inconsistency and bias:

Dr. Susan Wood, a former F.D.A. assistant commissioner who resigned in 2005 to protest the Bush administration’s handling of Plan B, said that there were many drugs available over the counter that had not been studied in pre-adolescents and that were far more dangerous to them.

“Acetaminophen can be fatal, but it’s available to everyone,” Dr. Wood noted. “So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?”

[musette_sf]

16. Health Secretary Overrules F.D.A. on Sale of Morning-After Pill

Source: New York Times

WASHINGTON — Health and Human Services Secretary Kathleen Sebelius overruled the Food and Drug Administration’s decision Wednesday that emergency contraceptives be sold freely over the counter, including to teenagers 16 years old and younger.

The pill, called Plan B One-Step, has been available without a prescription to women 17 and older, but those 16 and younger have needed a prescription — and still will because of Ms. Sibelius’s decision. In some states, pharmacists can write the prescription on the spot for teenagers. But the restrictions have meant the pills were only dispensed from behind the counter — making them more difficult for everyone to get. The pill, if taken after unprotected sex, halves the risk of a pregnancy.

Under the law, Ms. Sebelius has the authority to overrule the agency, but no health secretary has ever done so, according to an F.D.A. spokeswoman. Her decision on an emotional issue that touches on parental involvement in birth control for teenaged children is likely to have powerful political reverberations in a presidential election season.

Read more: http://www.nytimes.com/2011/12/08/health/policy/sebelius-overrules-fda-on-freer-sale-of-emergency-contraceptives.html

---

This had better be the red meat that the Obama administration is throwing to the UCCSB in order to preserve the HHS Contraceptive Mandate. Because if it's not, it looks like this administration is throwing women under the bus.

[earthside]

17. What?

I don't understand this.

The United States Conference of Catholic Bishops don't deserve any special consideration since this isn't really an issue that affects them ... they are celibate (right?).

[musette_sf]

18. The UCCSB is fighting the HHS contraceptive mandate tooth and nail.

And this Administration seems to be bending over backwards to accommodate them, to the detriment of the civil, human and Constitutional rights of female US citizens.

I am hoping that this action by Sebelius is the concession being made to the UCCSB to save the contraceptive mandate. Because if it's not, then the War on Women has gone bi-partisan.

[atreides1]

19. Yes they are celibate

But that's because some monk didn't get the memo in time and left out the 'R'.:evilgrin:

[Seedersandleechers]

20. My take on this

is that KS is concerned that some younger teenage girls will not use the pill as it was intended to be used. Say perhaps some of the girls will think it's okay to have sex and take the pills on a regular basis which is clearly not the intent. I worked in a women's clinic years ago and discovered some of the part time young girls who were working as receptionist were taking our estrace cream for their yeast infections. Please tell me if you think I'm wrong on this.

[hedgehog]

22. I was wondering if this was the concern. How often can the pill be taken?

[Seedersandleechers]

28. at the doses you need to take for effect

not routinely.

[glinda]

26. Think there is some truth in what you are saying. Still needs to be accessible.

[Seedersandleechers]

29. I agree, but as a nurse I can understand her concern.

[kath]

23. Another great Obama appointment, eh?

Sheesh. :banghead: :banghead:

[alp227]

24. If it's legal for 15 and 16 yos to have sex

(varies by state) then this decision violates equalprotection clause

[Freddie Stubbs]

30. If that were true, why haven't the courts struck down parental notification laws for abortions?

[PSPS]

27. Not surprising with US politics being so theocratic.

[Avalux]

32. So....Sebelius knows better than the experts?

This isn't about safety of the drug, it's about limiting access to young women who may be in trouble. Despicable.

[closeupready]

34. Sebelius showing her true DLC colors.

K&R for everyone to see.

[suffragette]

36. Medical Groups Denounce HHS Decision / Obama supports it

http://www.cbsnews.com/8301-504763_162-57339334-10391704/morning-after-pill-block-medically-inexplicable-experts-say/

"Today's decision by HHS is a profound disappointment for the health of adolescent girls and is inconsistent with what we know about the safety and benefits of emergency contraception," Dr. Leslie Walker, president of Society for Adolescent Health and Medicine (SAHM), said in a written statement.

SAHM teamed up with the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) to denounce Sebelius' decision in a jointly released statement.

"Today's disappointing decision by HHS counters advancements in public health and welfare by minimizing young women's ability to safely and responsibly control and protect their reproductive health," Dr. James N. Martin, Jr., president of ACOG, added in the statement. "The College will continue to push for removing the unnecessary age restriction for over-the-counter access to emergency contraception."

Link to full release here:
http://www.acog.org/~/media/News%20Releases/20111207Release.ashx


http://thinkprogress.org/health/2011/12/08/385145/obama-backs-sebelius-decision-to-limit-availability-of-plan-b/
Obama said he did not personally intervene in Sebelius’ decision, but explained that “as the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over the counter medicine.” Sebelius “could not be confident that a 10-year-old or 11-year-old going to a drug store would be able to, alongside bubble gum or batteriers be able to buy a medication that potentially if not used properly can have an adverse effect,” he said, adding, “I think most parents would probably feel the same way”:

OBAMA: When it comes to 12-year-olds or 13-year-olds, the question is, can we have confidence that they would potentially use Plan B properly and her judgment was that there was not enough evidence that this potentially could be used improperly in a way that had adverse health effects on those young people.

REPORTER: Do you support the decision?

OBAMA: I do.



I agree with Dr. Susan Wood:
http://www.nationaljournal.com/healthcare/hhs-decision-tarnishes-obama-s-pledge-to-put-science-first-20111207

It was déjà vu for Dr. Susan Wood, former head of the FDA's Office of Women's Health, who resigned in protest over the agency's handling of the drug in 2005, under the Bush administration.

“This decision is stunning," Wood said in a statement. "I had come to believe that the FDA would be allowed to make decisions based on science and the public's health. Sadly, once again, FDA has been overruled and not allowed to do its job.”