Emergency Contraception Set for Unrestricted Over-The-counter Sales
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The NATION Health news at the national and federal levels Emergency contraception set for unrestricted over-the-counter sales A FTER YEARS of court battles over the accessibüity of emergency contraception, the drug wül soon be avaÜable over the counter and without age or point-of-sale restrictions. Advocates are haiUng the latest court-directed turn- around as a victory for sci- ence and women's health. "We are relieved that the administration has finally listened to science and medicine and that women of aU ages wul have access to emergency contracep- tion," said Nancy Stanwood, MD, MPH, Physicians for Reproductive Health board chair. "For over a decade, (our organization has) endorsed an end to the unfounded and harmful age restrictions on this safe and effective medication." In April, a U.S. district court judge ordered the U.S. Food and Drug Administration to make emergency contraception avaÜable over the counter without restriction, citing earlier actions by U.S. Health and Human Ser- vices Secretary Kathleen Sebelius as "politicaUy motivated, scientificaüy unjustified and contrary to agency precedent." In late 2011, Sebelius blocked FDA's approval of emer- gency contraception Plan B One-Step's over-the- counter application. Unfortunately, the Obama administration appealed the AprÜ ruling. Around the same time, FDA approved an application to offer Plan B over the counter without a prescrip- tion to girls and women ages 15 years old and older, though many advocates questioned how 15-year- olds ^vould be able to prove their age without government-issued identifi- cation. But in June, the fed- eral government dropped its appeal, and FDA said it ' WÜ1 allow the sale of one- piü versions of emergency contraception without age restrictions beginning with Plan B One-Step. Before the April ruling, women younger than 17 had to get a doctor's prescription to access aU forms of emergency contraception. "For pediatricians, the science has always been clear: Emergency contra- ception is a safe, effective tool to prevent unintended pregnancy in adolescents of any reproductive age," said American Academy of Pediatrics President Thomas Mclnemy, MD, FAAP, in a joint news release with the American Congress of Obstetricians and Gynecologists and the Society for Adolescent Health and Medicine. "Since nearly 80 percent of pregnancies in adolescents are unintended, allowing unrestricted access to emergency contraception products is a historic step forward in protecting the health of our patients who are sexually active." After the government withdrew its appeal of the AprÜ ruling, FDA invited Plan B's manufacturer to submit a supplemental new drug application with proposed labeling require- ments that would aüow the drug to be sold over the counter without age restrictions. A June 10 let- ter from a U.S. attorney to U.S. District Court Judge Edward Korman, who issued the April ruling, stated that upon receiving the new drug application, "FDA will approve it w^ith- out delay." And on June 20, FDA approved Plan B One- Step as a nonprescription product for all women. FDA first approved Plan B as an emergency contra- ceptive for prescription use in 1999, and Plan B's manu- facturers first appUed to offer the drug over the counter a decade ago. Emergency contracep- tion can reduce the risk of pregnancy up to 120 hours after unprotected sex or contraception faüure. For more information on the recent court decisions, visit www.reproductive rights.org. • — Kim Krisberg CDC campaign stresses patient-doctor relationship in kicking smoking habit A CENTERS FOR Disease Control and Preven- tion campaign to get smok- ers to quit the habit unveÜed a new approach this spring: the importance of talking with a doctor. The Talk With Your Doc- tor initiative is the newest part of CDC's Tips From Former Smokers Campaign, which has used hard-hitting ads since 2012 to show the physical effects of smoking. Ads for the new initiative aired from May 27 through June 2 with the tagline "You can quit. Talk to your doctor for help." During a May 22 news conference in Washington, D.C., then-Surgeon General Regina Benjamin, MD, MBA, said patients whose physicians advise them to quit have a 66 percent suc- cess rate for quitting, but today one in five adults in the U.S. still smokes. "As physicians, we need to discuss various forms of assistance, such as nicotine replacement therapy and prescriptions," Benjamin said. The American Academy of Pediatrics, American Medical Association and other physician groups have partnered with CDC to teach doctors to address tobacco use with patients. The American Academy of Famüy Physicians has produced a toolkit that includes resources such as tip sheets in English and Spanish about adopting healthy habits to stay smoke-free. Jeff Cain, MD, FAAP, president of the American Academy of FamÜy Physi- cians, said during the news conference that patients might think physicians are too busy treating heart dis- ease, lung disease or cancer to have time to talk about smoking, yet do not realize that the No. 1 cause of those diseases is smoking. He said even if patients have tried before but faÜed or are embarrassed, physi- cians are wiüing to talk to them about how^ to quit. The new initiative also encourages health care providers to initiate discus- sions on quitting with their patients. "Today I'm teUing you that America's physicians have been trained to talk with you," Cain said. "They have the time to talk with you. They're able to talk with you and they w^ant to talk with you. The door is open." More pediatricians need to talk with patients and their parents about the effects of secondhand smoke, said Thomas Mcln- emy, MD, MAAP, president of the American Academy of Pediatrics. Only three out of 10 parents say their chüdren's physician asked them about exposure to second- hand smoke in the home and only two out of 10 parents who smoked were advised to keep their homes smoke free, accord- ing to data from the National Social Climate Survey of Tobacco Control. The website for the cam- paign features fact sheets with tips for starting the conversation with patients, downloadable posters, informational videos and more. For more information, visit www.cdc.gov/tips/ hep. S — Natalie McCill Photo by Natalie McGill Terrie Hall, who is featured in CDC's Tips from Former Smokers campaign, speaks at a May news conference in Washington, D.C. Benjamin completes term as US, surgeon general S URGEONS GENERAL of the U.S. have the opportunity to make a major impact on the coun- try during the years that they serve, and Surgeon General Regina Benjamin, MD, MBA, WÜ1 be remem- bered for teaching America how to walk again. In response to Ben- jamin's June 12 announce- ment that she would be stepping down in July, APHA praised her service as the 18th surgeon gen- eral of the U.S. APHA Executive Director Georges Benjamin, MD, noted Regina Benjamin's focus on walking as exercise. "She elevated walking as a simple yet important form of physical activity available to most Ameri- cans," he said in a state- ment. "Through her walks, she brought communities together and worked to make being healthy fun again." Georges Benjamin also noted that as surgeon gen- eral, Regina Benjamin con- tinued the tradition of her predecessors by advocat- ing for reduced tobacco use in the U.S. Two tobacco reports released during her tenure focused on how tobacco smoke causes disease and pre- venting tobacco use among youth. During her four years of service, Benjamin also led the release of the National Prevention Strategy, a roadmap to guide health partners at the local, national and international levels to reduce health dis- parities and improve the health of all Americans. She noted in her farewell statement that there have been positive trends in leading health indicators, including decreases in youth expo- sure to secondhand smoke and overall cancer deaths. "(Benjamin) has been a remarkable advocate in promoting the value of prevention as a national health priority," Georges Benjamin said. "We are extraordinarüy grateful for her strong public health leadership." • — Charlotte Tucker THE NATION'S HEALTH • AUGUST 2013
Transcript of Emergency Contraception Set for Unrestricted Over-The-counter Sales
The NATIONHealth news at the national and federal levels
Emergency contraception set forunrestricted over-the-counter sales
AFTER YEARS of courtbattles over the
accessibüity of emergencycontraception, the drug wülsoon be avaÜable over thecounter and without age orpoint-of-sale restrictions.Advocates are haiUng thelatest court-directed turn-around as a victory for sci-ence and women's health.
"We are relieved that theadministration has finallylistened to science andmedicine and that womenof aU ages wul have accessto emergency contracep-tion," said Nancy Stanwood,MD, MPH, Physicians forReproductive Health boardchair. "For over a decade,(our organization has)endorsed an end to theunfounded and harmful agerestrictions on this safe andeffective medication."
In April, a U.S. districtcourt judge ordered theU.S. Food and DrugAdministration to makeemergency contraceptionavaÜable over the counterwithout restriction, citingearlier actions by U.S.Health and Human Ser-vices Secretary KathleenSebelius as "politicaUymotivated, scientificaüyunjustified and contrary toagency precedent." In late2011, Sebelius blockedFDA's approval of emer-gency contraception PlanB One-Step's over-the-counter application.
Unfortunately, theObama administrationappealed the AprÜ ruling.Around the same time, FDAapproved an application tooffer Plan B over thecounter without a prescrip-tion to girls and womenages 15 years old and older,though many advocatesquestioned how 15-year-olds ^vould be able toprove their age withoutgovernment-issued identifi-cation. But in June, the fed-eral government droppedits appeal, and FDA said it
' WÜ1 allow the sale of one-piü versions of emergencycontraception without agerestrictions beginning withPlan B One-Step.
Before the April ruling,women younger than 17
had to get a doctor'sprescription to access aUforms of emergencycontraception.
"For pediatricians, thescience has always beenclear: Emergency contra-ception is a safe, effectivetool to prevent unintendedpregnancy in adolescentsof any reproductive age,"said American Academy ofPediatrics PresidentThomas Mclnemy, MD,FAAP, in a joint newsrelease with the AmericanCongress of Obstetriciansand Gynecologists and theSociety for AdolescentHealth and Medicine."Since nearly 80 percent ofpregnancies in adolescentsare unintended, allowingunrestricted access toemergency contraceptionproducts is a historic stepforward in protecting thehealth of our patients whoare sexually active."
After the governmentwithdrew its appeal of theAprÜ ruling, FDA invitedPlan B's manufacturer tosubmit a supplementalnew drug application withproposed labeling require-ments that would aüow thedrug to be sold over thecounter without agerestrictions. A June 10 let-ter from a U.S. attorney toU.S. District Court JudgeEdward Korman, whoissued the April ruling,stated that upon receivingthe new drug application,"FDA will approve it w ith-out delay." And on June 20,FDA approved Plan B One-Step as a nonprescriptionproduct for all women.
FDA first approved PlanB as an emergency contra-ceptive for prescription usein 1999, and Plan B's manu-facturers first appUed tooffer the drug over thecounter a decade ago.
Emergency contracep-tion can reduce the risk ofpregnancy up to 120 hoursafter unprotected sex orcontraception faüure.
For more information onthe recent court decisions,visit www.reproductiverights.org. •
— Kim Krisberg
CDC campaign stresses patient-doctorrelationship in kicking smoking habit
ACENTERS FOR DiseaseControl and Preven-
tion campaign to get smok-ers to quit the habitunveÜed a new approachthis spring: the importanceof talking with a doctor.
The Talk With Your Doc-tor initiative is the newestpart of CDC's Tips FromFormer Smokers Campaign,which has used hard-hittingads since 2012 to show thephysical effects of smoking.Ads for the new initiativeaired from May 27 throughJune 2 with the tagline"You can quit. Talk to yourdoctor for help."
During a May 22 newsconference in Washington,D.C., then-Surgeon GeneralRegina Benjamin, MD,MBA, said patients whosephysicians advise them toquit have a 66 percent suc-cess rate for quitting, buttoday one in five adults inthe U.S. still smokes.
"As physicians, we needto discuss various forms ofassistance, such as nicotinereplacement therapy andprescriptions," Benjaminsaid.
The American Academyof Pediatrics, AmericanMedical Association andother physician groupshave partnered with CDC toteach doctors to addresstobacco use with patients.
The American Academyof Famüy Physicians hasproduced a toolkit thatincludes resources such astip sheets in English andSpanish about adoptinghealthy habits to staysmoke-free.
Jeff Cain, MD, FAAP,president of the AmericanAcademy of FamÜy Physi-cians, said during the newsconference that patientsmight think physicians are
too busy treating heart dis-ease, lung disease or cancerto have time to talk aboutsmoking, yet do not realizethat the No. 1 cause ofthose diseases is smoking.He said even if patientshave tried before but faÜedor are embarrassed, physi-cians are wiüing to talk tothem about how^ to quit.
The new initiative alsoencourages health careproviders to initiate discus-sions on quitting with theirpatients.
"Today I'm teUing youthat America's physicianshave been trained to talkwith you," Cain said. "Theyhave the time to talk withyou. They're able to talkwith you and they w ant totalk with you. The door isopen."
More pediatricians needto talk with patients andtheir parents about theeffects of secondhandsmoke, said Thomas Mcln-emy, MD, MAAP, presidentof the American Academyof Pediatrics.
Only three out of 10parents say their chüdren'sphysician asked themabout exposure to second-hand smoke in the homeand only two out of 10parents who smoked wereadvised to keep theirhomes smoke free, accord-ing to data from theNational Social ClimateSurvey of Tobacco Control.
The website for the cam-paign features fact sheetswith tips for starting theconversation with patients,downloadable posters,informational videos andmore.
For more information,visit www.cdc.gov/tips/hep. S
— Natalie McCill
Photo by Natalie McGill
Terrie Hall, who is featured in CDC's Tips from Former Smokerscampaign, speaks at a May news conference in Washington, D.C.
Benjamincompletes termas US, surgeongeneral
SURGEONS GENERAL ofthe U.S. have the
opportunity to make amajor impact on the coun-try during the years thatthey serve, and SurgeonGeneral Regina Benjamin,MD, MBA, WÜ1 be remem-bered for teaching Americahow to walk again.
In response to Ben-jamin's June 12 announce-ment that she would bestepping down in July,APHA praised her serviceas the 18th surgeon gen-eral of the U.S. APHAExecutive Director GeorgesBenjamin, MD, notedRegina Benjamin's focuson walking as exercise.
"She elevated walkingas a simple yet importantform of physical activityavailable to most Ameri-cans," he said in a state-ment. "Through her walks,she brought communitiestogether and worked tomake being healthy funagain."
Georges Benjamin alsonoted that as surgeon gen-eral, Regina Benjamin con-tinued the tradition of herpredecessors by advocat-ing for reduced tobaccouse in the U.S. Twotobacco reports releasedduring her tenure focusedon how tobacco smokecauses disease and pre-venting tobacco useamong youth.
During her four years ofservice, Benjamin also ledthe release of the NationalPrevention Strategy, aroadmap to guide healthpartners at the local,national and internationallevels to reduce health dis-parities and improve thehealth of all Americans.
She noted in herfarewell statement thatthere have been positivetrends in leading healthindicators, includingdecreases in youth expo-sure to secondhand smokeand overall cancer deaths.
"(Benjamin) has been aremarkable advocate inpromoting the value ofprevention as a nationalhealth priority," GeorgesBenjamin said. "We areextraordinarüy grateful forher strong public healthleadership." •
— Charlotte Tucker
T H E N A T I O N ' S H E A L T H • A U G U S T 2 0 1 3
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