Re: Plan B approved OTC

From:

nfpprofessionals [mailto:nfpprofessionals ]

On Behalf Of

Picella, NP

Sent: Friday, August

25, 2006 1:35

PM

Subject: Re:

Plan B approved OTC

You bring up a good question.

Here is something I have

been wanting to point out for a while.

As I understand it, it is not illegal for an MD. For a mid-level

practitioner,

however, this may be another story. Just to be clear, I am only

talking

about using already available standard birth control pills but just in

high

dosages for the abortifacient (if you will) effects -- a practice that

has been

going on for a long time. Believe me, I worked in a clinic and I

recall

the drug sample cabinet in the back where there was always a partly

used pack

that the doctors would access to get the woman started.

Back to the point about mid-level practitioners (PA, NP, CNM). Are

there not

legal restrictions on "off label prescribing?" In CA (now it is going

to be different in every state) I am under the impression that using a

medication "off label" (i.e., in a manner that is not approved

by the FDA) is somehow a scope of practice violation. I used to use

this as an

excuse for not getting involved in it.

--

Sheila St. wrote:

On their

site, they have a chart listing

various oral contraceptives, with very specific instructions on taking

them in

quantity 12 hours apart as emergency contraception. I understand that

is what

Plan B is, but is it legal they advise women to take their prescribed

medication, oral contraceptives, in a manner which other than which the

doctor

prescribed them? Just seems like that would be inadvisable, if not

illegal for

them to post…..??

Sheila

St.

Executive

Director

California Association of Natural

Family

Planning

1217 Tyler St.

Salinas, Ca. 93906

1-877-33-CANFP

From:

nfpprofessionals [mailto:nfpprofessionals ]

On Behalf Of

Picella, NP

Sent: Friday, August

25, 2006

12:35 PM

http://plannedparenthood.com/pp2/portal/files/portal/webzine/newspoliticsactivism/fean-060824-ecatlast.xml

Subject: Re:

Plan B approved OTC

If anyone can stand reading

it, you really should read

the breaking news article that Planned Parenthood has on their website.

Fehring, wrote:

:

Thanks for

the clarification that both Men

and Women will have over the counter access to Plan B. I am sure that

Lee

Ann will forgive your theft!

I see in the

NY Times that the maker of

Plan B (Barr) also foresees a doubling of their profits (i.e., from $

35

million to about 70 million) over the next year – but it is only a

minor

money maker for the company.

KUDOS – on

your appearance and

responses on the PBS Lehrer NewsHour Report yesterday in regards to the

new

“moral” stem cell approach and clarifying that the embryos were

actually destroyed in the study that appeared in the journal Science.

The

California Stem Cell scientist that was on the panel with you (to me)

seemed

phony when he tried to show so much concern that they are trying to

find cures

for all diabetes, Parkinson, etc. I am sure they are doing this

research

for good will and not to make profits. And then he had the gall to

state

that the Catholic Church is against all stem cell research. He was

blowing smoke and skirting the real issues that you brought up.

J.

Fehring

Marquette University

From: nfpprofessionals@

yahoogroups.com [mailto:nfpprofessionals ]

On Behalf Of

Doerflinger

Sent: Friday, August

25, 2006 6:44

AM

jstanforddfpm (DOT) utah.edu

Subject: Re:

Plan

B approved OTC

The headline is a

deception.

I am told by FDA officials that it was approved OTC for all MEN and

women 18

and over. Which pretty much makes the claim to be trying to keep this

out

of the hands of minor girls a mockery. What use would men have for it,

except to give it to their underage girlfriends?

- Doerflinger,

stealing

Lee Ann's address for a moment

Plan B approved OTC

FYI

The web link at the end

has a lot

more information.

I note that the product

label does

contain information about the postfertilization mechanism of action,

although

not as clearly as I would have liked.

Effectiveness is still

overstated.

Joe

FOR

IMMEDIATE RELEASE

P06-118

August 24, 2006

Media

Inquiries:

Zawisza,

Consumer Inquiries:

888-INFO-FDA

FDA

Approves

Over-the-Counter Access for Plan B for Women 18 and Older

Prescription Remains Required for Those 17 and Under

The U.S. Food and Drug

Administration (FDA) today

announced approval of Plan B, a contraceptive drug, as an

over-the-counter

(OTC) option for women aged 18 and older. Plan B is often referred to

as

emergency contraception or the "morning after pill." It contains an

ingredient used in prescription birth control pills--only in the case

of Plan

B, each pill contains a higher dose and the product has a different

dosing

regimen. Like other birth control pills, Plan B has been available to

all women

as a prescription drug. When used as directed, Plan B effectively and

safely

prevents pregnancy. Plan B will remain available as a prescription-only

product for women age 17 and under.

Duramed, a subsidiary of

Barr Pharmaceuticals, will

make Plan B available with a rigorous labeling, packaging, education,

distribution and monitoring program. In the CARE (Convenient Access,

Responsible

Education) program Duramed commits to:

· Provide

consumers and healthcare professionals with labeling and education

about the

appropriate use of prescription and OTC Plan B, including an

informational

toll-free number for questions about Plan B;

· Ensure that

distribution of Plan B will only be through licensed drug wholesalers,

retail

operations with pharmacy services, and clinics with licensed healthcare

practitioners, and not through convenience stores or other retail

outlets where

it could be made available to younger women without a prescription;

· Packaging

designed to hold both OTC and prescription Plan B. Plan B will be

stocked by

pharmacies behind the counter because it cannot be dispensed without a

prescription or proof of age; and

· Monitor the

effectiveness of the age restriction and the safe distribution of OTC

Plan B to

consumers 18 and above and prescription Plan B to women under 18.

Today's action concludes

an extensive process that

included obtaining expert advice from a joint meeting of two FDA

advisory

committees and providing an opportunity for public comment on issues

regarding

the scientific and policy questions associated with the application to

switch

Plan B to OTC use. Duramed's application raised novel issues regarding

simultaneously marketing both prescription and non-prescription Plan B

for emergency

contraception, but for different populations, in a single package.

The agency remains

committed to a careful and

rigorous scientific process for resolving novel issues in order to

fulfill its

responsibility to protect the health of all Americans.

For more information on

Plan B and today's action,

please see: http://www.fda.gov/cder/drug/infopage/planB/default.htm.

--

______________________________

ph B. Stanford, MD, MSPH

University of Utah

Department of Family

and

Preventive Medicine

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<http://www.fda.gov/cder/drug/infopage/planB/default.htm>http://www.f

August 26, 2006

Our local paper had an article on this as well as a chart and graphic

(!) that showed the three commonly considered mechanisms of action

of map, one of which was blocking implantation. I mention this to

encourage others to pester their newspapers to reveal this effect.

It has been quite a few years that we have argued this mechansim

exists, only to see it excluded. Actually, not only excluded but

comments made that gave the impression it didn't exist. One friend

had to supply an insert from the pill packaging even to be able to

say it in her own letter to the editor!

I'm not sure what finally made the difference. The last time I

sent something in, it was an email from Trussell, the

researcher, in which he documented that this was indeed a mode of

action. I had his permission to forward it to the editor.

Now we will work on the pregnancy issue, since the comment is made

that a pregnancy is not ended! I'm still not sure how to tackle

that except to disclose the politics involved in changing the

definition and making the point that a real human is denied

implantation and that directly results in his death. A friend is

currently doing a letter to that effect, if it is printed I will

post a link.

a Johannes

>

> FYI

> The web link at the end has a lot more information.

> I note that the product label does contain

> information about the postfertilization mechanism

> of action, although not as clearly as I would

> have liked.

> Effectiveness is still overstated.

> Joe

>

> FOR IMMEDIATE RELEASE

> P06-118

> August 24, 2006

> Media Inquiries:

> Zawisza,

> Consumer Inquiries:

> 888-INFO-FDA

>

> FDA Approves Over-the-Counter Access for Plan B for Women 18 and

Older

> Prescription Remains Required for Those 17 and Under

>

> The U.S. Food and Drug Administration (FDA) today

> announced approval of Plan B, a contraceptive

> drug, as an over-the-counter (OTC) option for

> women aged 18 and older. Plan B is often referred

> to as emergency contraception or the " morning

> after pill. " It contains an ingredient used in

> prescription birth control pills--only in the

> case of Plan B, each pill contains a higher dose

> and the product has a different dosing regimen.

> Like other birth control pills, Plan B has been

> available to all women as a prescription drug.

> When used as directed, Plan B effectively and

> safely prevents pregnancy. Plan B will remain

> available as a prescription-only product for

> women age 17 and under.

> Duramed, a subsidiary of Barr Pharmaceuticals,

> will make Plan B available with a rigorous

> labeling, packaging, education, distribution and

> monitoring program. In the CARE (Convenient

> Access, Responsible Education) program Duramed

> commits to:

> · Provide consumers and

> healthcare professionals with labeling and

> education about the appropriate use of

> prescription and OTC Plan B, including an

> informational toll-free number for questions

> about Plan B;

> · Ensure that

> distribution of Plan B will only be through

> licensed drug wholesalers, retail operations with

> pharmacy services, and clinics with licensed

> healthcare practitioners, and not through

> convenience stores or other retail outlets where

> it could be made available to younger women

> without a prescription;

> · Packaging designed to

> hold both OTC and prescription Plan B. Plan B

> will be stocked by pharmacies behind the counter

> because it cannot be dispensed without a

> prescription or proof of age; and

> · Monitor the

> effectiveness of the age restriction and the safe

> distribution of OTC Plan B to consumers 18 and

> above and prescription Plan B to women under 18.

> Today's action concludes an extensive process

> that included obtaining expert advice from a

> joint meeting of two FDA advisory committees and

> providing an opportunity for public comment on

> issues regarding the scientific and policy

> questions associated with the application to

> switch Plan B to OTC use. Duramed's application

> raised novel issues regarding simultaneously

> marketing both prescription and non-prescription

> Plan B for emergency contraception, but for

> different populations, in a single package.

> The agency remains committed to a careful and

> rigorous scientific process for resolving novel

> issues in order to fulfill its responsibility to

> protect the health of all Americans.

> For more information on Plan B and today's

> action, please see:

>

da.gov/cder/drug/infopage/planB/default.htm.

> --

> ______________________________

> ph B. Stanford, MD, MSPH

> University of Utah

> Department of Family and Preventive Medicine

> jstanford@...

>

August 26, 2006

, I thought the same thing and think that there should be

something included that criminalizes secondary (and primary)

distribution to minors. Is there?

kristina

>

> Plan B approved OTCThe headline is a deception. I am told by FDA

officials that it was approved OTC for all MEN and women 18 and

over. Which pretty much makes the claim to be trying to keep this

out of the hands of minor girls a mockery. What use would men have

for it, except to give it to their underage girlfriends?

>

> - Doerflinger, stealing Lee Ann's address for a moment

> Plan B approved OTC

>

> FYI

> The web link at the end has a lot more information.

> I note that the product label does contain information about the

postfertilization mechanism of action, although not as clearly as I

would have liked.

> Effectiveness is still overstated.

> Joe

>

> FOR IMMEDIATE RELEASE

> P06-118

> August 24, 2006

> Media Inquiries:

> Zawisza,

> Consumer Inquiries:

> 888-INFO-FDA

>

> FDA Approves Over-the-Counter Access for Plan B for Women 18 and

Older

> Prescription Remains Required for Those 17 and Under

>

> The U.S. Food and Drug Administration (FDA) today announced

approval of Plan B, a contraceptive drug, as an over-the-counter

(OTC) option for women aged 18 and older. Plan B is often referred

to as emergency contraception or the " morning after pill. " It

contains an ingredient used in prescription birth control pills--

only in the case of Plan B, each pill contains a higher dose and the

product has a different dosing regimen. Like other birth control

pills, Plan B has been available to all women as a prescription

drug. When used as directed, Plan B effectively and safely prevents

pregnancy. Plan B will remain available as a prescription-only

product for women age 17 and under.

> Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B

available with a rigorous labeling, packaging, education,

distribution and monitoring program. In the CARE (Convenient Access,

Responsible Education) program Duramed commits to:

> · Provide consumers and healthcare

professionals with labeling and education about the appropriate use

of prescription and OTC Plan B, including an informational toll-free

number for questions about Plan B;

> · Ensure that distribution of Plan B

will only be through licensed drug wholesalers, retail operations

with pharmacy services, and clinics with licensed healthcare

practitioners, and not through convenience stores or other retail

outlets where it could be made available to younger women without a

prescription;

> · Packaging designed to hold both OTC

and prescription Plan B. Plan B will be stocked by pharmacies behind

the counter because it cannot be dispensed without a prescription or

proof of age; and

> · Monitor the effectiveness of the age

restriction and the safe distribution of OTC Plan B to consumers 18

and above and prescription Plan B to women under 18.

> Today's action concludes an extensive process that included

obtaining expert advice from a joint meeting of two FDA advisory

committees and providing an opportunity for public comment on issues

regarding the scientific and policy questions associated with the

application to switch Plan B to OTC use. Duramed's application

raised novel issues regarding simultaneously marketing both

prescription and non-prescription Plan B for emergency

contraception, but for different populations, in a single package.

> The agency remains committed to a careful and rigorous

scientific process for resolving novel issues in order to fulfill

its responsibility to protect the health of all Americans.

> For more information on Plan B and today's action, please see:

http://www.fda.gov/cder/drug/infopage/planB/default.htm<http://www.fd

a.gov/cder/drug/infopage/planB/default.htm>.

> --

> ______________________________

> ph B. Stanford, MD, MSPH

> University of Utah

> Department of Family and Preventive Medicine

> jstanford@...

>

August 29, 2006

Just FYI

A few years ago, the FDA issued specific guidance for using

multiple pills of oral contraceptives as emergency contraception, on a

prescription basis- of course regular oral contraceptives are

prescription. So this type of thing was specifically approved by

the FDA around 1997 or 1998, at least under clinician advice. If

you really want to know, you can find it somewhere on their website.

Of course, it's another issue as to patients taking a prescription in

a way different than their provider gave it.

Joe

Sheila et al.,

In some urgent care centers (I've seen this myself) this same

information is given to the woman in the form of a handout explaining

what to do when they leave. In one place that I worked, the protocol

was hanging up in the physician's chart room, just in case anyone had

any questions (in the form of a wall chart). I recall at the

same place, there was a " new grad " PA who had the typical

" gung ho - I know everything now -- in my opinion very dangerous "

attitude who asked me the strangest question once: " So anything

new? Any abortions? " -- as if it was a great thing to do.

--

Sheila St. wrote:

But this is even more radical than the office visit

situation you describe.. This is a WEBSITE advocating taking

prescribed medication in a dramatically different way than prescribed

by their physician. See below:

Swallow the pills in the first dose as soon as

possible, up to 120 hours - five days - after having unprotected

sex. EC may cause nausea and

vomiting. This risk is much higher for combination pills than for

progestin-only pills. To reduce the risk of nausea, you may want to

take an anti-nausea medication, such as Dramamine® or Bonine® one

hour before taking EC.

If you are taking the pills in two doses, swallow

the second dose 12 hours after taking the first dose. If you threw up after the first dose, be sure

to use an anti-nausea medication one hour before taking the second

dose. Or you may want to take the second dose as a vaginal suppository

by inserting the pills with your fingers as high into the vagina as

you can reach. (The medication will be absorbed through the vaginal

tissue.)

If you vomit the second dose, do not take any extra

pills. They probably won't reduce the risk of pregnancy. But they will

probably make you sick to your stomach.

Pill Brand

Manufacturer

1st Dose

2nd Dose (12 hrs later)

Progestin-only Pills

Plan B®

Barr

1 white pill

or 2 white pills in one dose

Ovrette®

Wyeth-Ayerst

20 yellow pills

or 40 yellow pills in one dose

Combination Hormone Pills

Alesse®

Wyeth-Ayerst

5 pink pills

Aviane®

Duramed

5 orange pills

Cryselle®

Barr

4 white pills

Enpresse®

Barr

4 orange pills

Lessina®

Barr

5 pink pills

Levlen®

Berlex

4 light orange pills

Levlite®

Berlex

5 pink pills

Levora®

4 white pills

Lo/Ovral®

Wyeth-Ayerst

4 white pills

LowOgestrel®

4 white pills

LuteraTM

5 white pills

Nordette®

Wyeth-Ayerst

4 light orange pills

Ogestrel®

2 white pills

Ovral®

Wyeth-Ayerst

2 white pills

Portia®

Barr

4 pink pills

Seasonale®

Barr

4 pink pills

SeasoniqueTM

Barr

4 blue-green pills

Tri-Levlen®

Berlex

4 yellow pills

Triphasil®

Wyeth-Ayerst

4 yellow pills

Trivora®

4 pink pills

With a regular 28-pill birth control pack, use any of

the first 21 pills for emergency contraception. Don't use the last

seven pills in a 28-day pack. They are only reminder pills that

contain no hormones. With Enpresse, use only the orange ones. With

Triphasil or Tri-Levlen, use only the yellow ones. With Trivora, use

only the pink ones.

Sheila

St.

Executive Director

California

Association of Natural Family Planning

1217 Tyler St.

Salinas, Ca.

93906

1-877-33-CANFP

From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of

Picella, NP

Sent: Friday, August 25, 2006 1:35 PM

Subject: Re: Plan B approved OTC

You bring up a good question. Here is something I have

been wanting to point out for a while.

As I understand it, it is not illegal for an MD. For a mid-level

practitioner, however, this may be another story. Just to be

clear, I am only talking about using already available standard birth

control pills but just in high dosages for the abortifacient (if you

will) effects -- a practice that has been going on for a long time.

Believe me, I worked in a clinic and I recall the drug sample cabinet

in the back where there was always a partly used pack that the doctors

would access to get the woman started.

Back to the point about mid-level practitioners (PA, NP, CNM). Are

there not legal restrictions on " off label prescribing? " In

CA (now it is going to be different in every state) I am under the

impression that using a medication " off label " (i.e., in a

manner that is not approved by the FDA) is somehow a scope of

practice violation. I used to use this as an excuse for not getting

involved in it.

--

Sheila St. wrote:

On their site, they have a chart listing various oral

contraceptives, with very specific instructions on taking them in

quantity 12 hours apart as emergency contraception. I understand that

is what Plan B is, but is it legal they advise women to take their

prescribed medication, oral contraceptives, in a manner which other

than which the doctor prescribed them? Just seems like that would be

inadvisable, if not illegal for them to postŠ..??

Sheila

St.

Executive Director

California

Association of Natural Family Planning

1217 Tyler St.

Salinas, Ca.

93906

1-877-33-CANFP

From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of

Picella, NP

Sent: Friday, August 25, 2006 12:35 PM

http://plannedparenthood.com/pp2/portal/files/portal/webzine/newspoliticsactivism/fean-060824-ecatl ast.xml

Subject: Re: Plan B approved OTC

If anyone can stand reading it, you really should read

the breaking news article that Planned Parenthood has on their

website.

Fehring, wrote:

:

Thanks for the clarification that both Men and Women

will have over the counter access to Plan B. I am sure that Lee

Ann will forgive your theft!

I see in the NY Times that the maker of Plan B (Barr)

also foresees a doubling of their profits (i.e., from $ 35 million to

about 70 million) over the next year - but it is only a minor money

maker for the company.

KUDOS - on your appearance and responses on the PBS

Lehrer NewsHour Report yesterday in regards to the new "moral"

stem cell approach and clarifying that the embryos were actually

destroyed in the study that appeared in the journal Science. The

California Stem Cell scientist that was on the panel with you (to me)

seemed phony when he tried to show so much concern that they are

trying to find cures for all diabetes, Parkinson, etc. I am sure

they are doing this research for good will and not to make profits.

And then he had the gall to state that the Catholic Church is against

all stem cell research. He was blowing smoke and skirting the

real issues that you brought up.

J. Fehring

Marquette University

From:

nfppro fessionals@ yahoogroups.com

[mailto:nfpprofessionals ] On Behalf Of

Doerflinger

Sent: Friday, August 25, 2006 6:44 AM

Subject: Re: Plan B approved

OTC

The headline is a deception. I am told by FDA

officials that it was approved OTC for all MEN and women 18 and over.

Which pretty much makes the claim to be trying to keep this out of the

hands of minor girls a mockery. What use would men have for it,

except to give it to their underage girlfriends?

- Doerflinger, stealing Lee Ann's address for

a moment

-----

Original Message -----

From: ph B. Stanford

Sent:

Thursday, August 24, 2006 11:54 AM

Subject:

Plan B approved OTC

FYI

The web

link at the end has a lot more information.

I note that

the product label does contain information about the postfertilization

mechanism of action, although not as clearly as I would have

liked.

Effectiveness is still overstated.

Joe

FOR

IMMEDIATE RELEASE

P06-118

August 24, 2006

Media

Inquiries:

Zawisza,

Consumer Inquiries:

888-INFO-FDA

FDA

Approves Over-the-Counter Access for Plan B for Women 18 and Older

Prescription Remains Required for Those 17 and Under

The U.S. Food

and Drug Administration (FDA) today announced approval of Plan B, a

contraceptive drug, as an over-the-counter (OTC) option for women aged

18 and older. Plan B is often referred to as emergency contraception

or the " morning after pill. " It contains an ingredient used

in prescription birth control pills--only in the case of Plan B, each

pill contains a higher dose and the product has a different dosing

regimen. Like other birth control pills, Plan B has been available to

all women as a prescription drug. When used as directed, Plan B

effectively and safely prevents pregnancy. Plan B will remain

available as a prescription-only product for women age 17 and

under.

Duramed, a

subsidiary of Barr Pharmaceuticals, will make Plan B available with a

rigorous labeling, packaging, education, distribution and monitoring

program. In the CARE (Convenient Access, Responsible Education)

program Duramed commits to:

·

; Provide consumers and healthcare professionals

with labeling and education about the appropriate use of prescription

and OTC Plan B, including an informational toll-free number for

questions about Plan B;

·

; Ensure that distribution of Plan B will only

be through licensed drug wholesalers, retail operations with pharmacy

services, and clinics with licensed healthcare practitioners, and not

through convenience stores or other retail outlets where it could be

made available to younger women without a prescription;

·

; Packaging designed to hold both OTC and

prescription Plan B. Plan B will be stocked by pharmacies behind the

counter because it cannot be dispensed without a prescription or proof

of age; and

·

; Monitor the effectiveness of the age

restriction and the safe distribution of OTC Plan B to consumers 18

and above and prescription Plan B to women under 18.

Today's

action concludes an extensive process that included obtaining expert

advice from a joint meeting of two FDA advisory committees and

providing an opportunity for public comment on issues regarding the

scientific and policy questions associated with the application to

switch Plan B to OTC use. Duramed's application raised novel issues

regarding simultaneously marketing both prescription and

non-prescription Plan B for emergency contraception, but for different

populations, in a single package.

The agency

remains committed to a careful and rigorous scientific process for

resolving novel issues in order to fulfill its responsibility to

protect the health of all Americans.

For more

information on Plan B and today's action, please see: http://www.fda.gov/cder/drug/infopage/planB/default.htm.

--

______________________________

ph B. Stanford, MD, MSPH

University of Utah

Department

of Family and Preventive Medicine

jstanford@...

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