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A u.s. District court judge ordered the FDA to make emergency contraception avaUable over the counter without restriction. Before the ruling, women younger than 17 had to get a doctor's prescription to access emergency contraception. FDA said it 'wul1 allow the sale of onepiu versions of emergency contraception without age restrictions.
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Emergency Contraception Set for Unrestricted Over-The-counter Sales
A u.s. District court judge ordered the FDA to make emergency contraception avaUable over the counter without restriction. Before the ruling, women younger than 17 had to get a doctor's prescription to access emergency contraception. FDA said it 'wul1 allow the sale of onepiu versions of emergency contraception without age restrictions.
A u.s. District court judge ordered the FDA to make emergency contraception avaUable over the counter without restriction. Before the ruling, women younger than 17 had to get a doctor's prescription to access emergency contraception. FDA said it 'wul1 allow the sale of onepiu versions of emergency contraception without age restrictions.
Emergency contraception set for unrestricted over-the-counter sales A FTER YEARS of court battles over the accessibity of emergency contraception, the drug wl soon be avaable 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 avaable over the counter without restriction, citing earlier actions by U.S. Health and Human Ser- vices Secretary Kathleen Sebelius as "politicaUy motivated, scientificay 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 Apr 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 ' W1 allow the sale of one- pi 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 Apr ruling, FDA invited Plan B's manufacturer to submit a supplemental new drug application with proposed labeling require- ments that would aow 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 faure. 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 unveed 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 Famy 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 Famy 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 faed or are embarrassed, physi- cians are wiing 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 chdren'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, W1 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, APHApraised 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 extraordinary grateful for her strong public health leadership." Charlotte Tucker THE NAT I ON' S HEALTH AUGUST 2 0 1 3