Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 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 RELEASEP06-118August 24, 2006 Media Inquiries: Zawisza, Consumer Inquiries:888-INFO-FDA FDA Approves Over-the-Counter Access for Plan B for Women 18 and OlderPrescription 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, MSPHUniversity of Utah Department of Family and Preventive Medicinejstanford@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 : 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 [mailto:nfpprofessionals ] On Behalf Of Doerflinger Sent: Friday, August 25, 2006 6:44 AM To: nfpprofessionals 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 jstanford@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 If anyone can stand reading it, you really should read the breaking news article that Planned Parenthood has on their website. http://plannedparenthood.com/pp2/portal/files/portal/webzine/newspoliticsactivism/fean-060824-ecatlast.xml 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 [mailto:nfpprofessionals ] On Behalf Of Doerflinger Sent: Friday, August 25, 2006 6:44 AM To: nfpprofessionals 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 To: nfpprofessionals 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 jstanforddfpm (DOT) utah.edu __________ NOD32 1.1725 (20060825) Information __________ This message was checked by NOD32 antivirus system. http://www.eset.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 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 www.canfp.org From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of Picella, NP Sent: Friday, August 25, 2006 12:35 PM To: nfpprofessionals 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. http://plannedparenthood.com/pp2/portal/files/portal/webzine/newspoliticsactivism/fean-060824-ecatlast.xml 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 To: nfpprofessionals 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 jstanforddfpm (DOT) utah.edu __________ NOD32 1.1725 (20060825) Information __________ This message was checked by NOD32 antivirus system. http://www.eset.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 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 www.canfp.org From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of Picella, NP Sent: Friday, August 25, 2006 12:35 PM To: nfpprofessionals 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. http://plannedparenthood.com/pp2/portal/files/portal/webzine/newspoliticsactivism/fean-060824-ecatlast.xml 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 To: nfpprofessionals 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 jstanforddfpm (DOT) utah.edu __________ NOD32 1.1725 (20060825) Information __________ This message was checked by NOD32 antivirus system. http://www.eset.com __________ NOD32 1.1725 (20060825) Information __________ This message was checked by NOD32 antivirus system. http://www.eset.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 and I also saw Doerflinger on The Newshour. You did a simply superb job, , educating the public in the truth. And, you had the last word, AMAZING! Thank you the Bishops and the Catholic community so well. Terry Maes : 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. FehringMarquette University From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of DoerflingerSent: Friday, August 25, 2006 6:44 AMTo: nfpprofessionals 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 FYIThe 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 RELEASEP06-118August 24, 2006Media Inquiries: Zawisza, Consumer Inquiries:888-INFO-FDA FDA Approves Over-the-Counter Access for Plan B for Women 18 and OlderPrescription Remains Required for Those 17 and UnderThe 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, MSPHUniversity of UtahDepartment of Family and Preventive Medicinejstanforddfpm (DOT) utah.edu Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 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 1 white pill or 2 white pills in one dose Ovrette® Wyeth-Ayerst 20 yellow pills 20 yellow pills or 40 yellow pills in one dose Combination Hormone Pills Alesse® Wyeth-Ayerst 5 pink pills 5 pink pills Aviane® Duramed 5 orange pills 5 orange pills Cryselle® Barr 4 white pills 4 white pills Enpresse® Barr 4 orange pills 4 orange pills Lessina® Barr 5 pink pills 5 pink pills Levlen® Berlex 4 light orange pills 4 light orange pills Levlite® Berlex 5 pink pills 5 pink pills Levora® 4 white pills 4 white pills Lo/Ovral® Wyeth-Ayerst 4 white pills 4 white pills LowOgestrel® 4 white pills 4 white pills LuteraTM 5 white pills 5 white pills Nordette® Wyeth-Ayerst 4 light orange pills 4 light orange pills Ogestrel® 2 white pills 2 white pills Ovral® Wyeth-Ayerst 2 white pills 2 white pills Portia® Barr 4 pink pills 4 pink pills Seasonale® Barr 4 pink pills 4 pink pills SeasoniqueTM Barr 4 blue-green pills 4 blue-green pills Tri-Levlen® Berlex 4 yellow pills 4 yellow pills Triphasil® Wyeth-Ayerst 4 yellow pills 4 yellow pills Trivora® 4 pink pills 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 www.canfp.org From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of Picella, NP Sent: Friday, August 25, 2006 1:35 PM To: nfpprofessionals 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 www.canfp.org From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of Picella, NP Sent: Friday, August 25, 2006 12:35 PM To: nfpprofessionals 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. http://plannedparenthood.com/pp2/portal/files/portal/webzine/newspoliticsactivism/fean-060824-ecatlast.xml 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 To: nfpprofessionals 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 jstanforddfpm (DOT) utah.edu __________ NOD32 1.1725 (20060825) Information __________ This message was checked by NOD32 antivirus system. http://www.eset.com __________ NOD32 1.1725 (20060825) Information __________ This message was checked by NOD32 antivirus system. http://www.eset.com Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 25, 2006 Report Share Posted August 25, 2006 I meant to say "for representing" the Bishops and the Catholic community so well. Creeping "oldtimers" sorry! Terry : 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. FehringMarquette University From: nfpprofessionals [mailto:nfpprofessionals ] On Behalf Of DoerflingerSent: Friday, August 25, 2006 6:44 AMTo: nfpprofessionals 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 FYIThe 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 RELEASEP06-118August 24, 2006Media Inquiries: Zawisza, Consumer Inquiries:888-INFO-FDA FDA Approves Over-the-Counter Access for Plan B for Women 18 and OlderPrescription Remains Required for Those 17 and UnderThe 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, MSPHUniversity of UtahDepartment of Family and Preventive Medicinejstanforddfpm (DOT) utah.edu Quote Link to comment Share on other sites More sharing options...
Guest guest Posted August 26, 2006 Report Share Posted August 26, 2006 Thanks, folks. For more on the exploding Lanza story on stem cells, see today's Washington Post online: http://www.washingtonpost.com/wp-dyn/content/article/2006/08/25/AR2006082501248.html Lee Ann is driving our daughter back to college in Worcester, Mass. On her return she'll find once again that I can't stay out of trouble without her help! - 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 RELEASEP06-118August 24, 2006 Media Inquiries: Zawisza, Consumer Inquiries:888-INFO-FDA FDA Approves Over-the-Counter Access for Plan B for Women 18 and OlderPrescription 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, MSPHUniversity of Utah Department of Family and Preventive Medicinejstanforddfpm (DOT) utah.edu Quote Link to comment Share on other sites More sharing options...
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