Judge Reverses Age Restrictions On Morning-After Contraceptives.

Sign up today to have the latest news in drug development worldwide delivered to your inbox ~ DIA's Global Smartbrief

US District Judge Edward Korman's decision Friday to reverse age restrictions on over-the-counter access to emergency contraceptive products was covered by all three broadcast networks, two which led with the story. Most of the media coverage noted Judge Edward Korman's frustrations with Health and Human Services Secretary Kathleen Sebelius having overruled a 2011 Food and Drug Administration recommendation to allow emergency contraception to be sold OTC to all ages; and several outlets noted that Korman, who presides over the District Court of Eastern New York, also placed some of the blame on the FDA for restricting access to the morning-after products in the past.

        The CBS Evening News (4/5, lead story, 3:10, Pelley) opened by reporting, "Anyone of any age may soon be able to walk into a drugstore and buy the morning-after pill. ... Throwing the dictionary at the Administration, Judge Edward Korman called the rule 'arbitrary, capricious, unreasonable and obviously political.'" CBS (Cordes) added that at the time of her 2011 decision, HHS Secretary Kathleen Sebelius "had argued younger girls might not understand the drug's labeling, leading to misuse."

        NBC Nightly News (4/5, lead story, 2:50, Williams) opened by saying, "This is a medical issue. It's a social issue. It's a moral issue for a lot of people." NBC (Gosk) added, "Barring an appeal, the legal battle over the drug and who should be allowed to buy it is over." On ABC World News (4/5, story 3, 2:15, Muir), Amy Robach reported, "Girls can soon be able buy the morning-after pill, 'Plan B', as easily as a bottle of aspirin."

        The AP (4/5) reported President Obama "had supported the 2011 decision setting age limits, and White House spokesman Jay Carney said Friday the president hasn't changed his position. 'He believes it was the right common-sense approach to this issue,'" Carney said.

        In a front-page story, the New York Times (4/6, A1, Belluck, Subscription Publication) reported that Judge Korman's decision "counteracts an unprecedented move" in 2011, by Secretary Sebelius, who "overruled" an FDA recommendation. In 2011, FDA Commissioner, Dr. Margaret A. Hamburg released a statement "saying that after rigorous study, it was safe to sell Plan B One-Step [levonorgestrel] over the counter for all ages." Moreover, the Times pointed out that scientists, "including those at the FDA, have been recommending unrestricted access for years, as have major medical groups, including the American Medical Association, the American Congress of Obstetricians and Gynecologists and the American Academy of Pediatrics."

        ABC News (4/6, Lupkin) on its website pointed out that Plan B, which prevents a "fertilized egg from attaching itself to the uterine wall," has been sold OTC in "China since 1998, and a study published in 2011 in the journal Human Reproduction involving 2,521 women found no adverse side effects. The most common side effects were vaginal bleeding and headaches."

        USA Today (4/5, Stanglin) reported that in his "59-page ruling," Judge Korman "said that Sebelius, in overruling the FDA, had forced the agency to 'to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability.'" Korman also "noted that the FDA itself had engaged in its own foot-dragging over the years, dating from the Bush administration, when the plaintiffs first began trying to get it to rule on Plan B more than 12 years ago. 'The FDA has engaged in intolerable delays in processing the petition,' he wrote."

        According to the Washington Post (4/6, Kliff, Dennis), the FDA initially, "approved Plan B as a prescription emergency contraceptive in 1999" and in 2003, its manufacturer asked the agency permit OTC sales of the drug but the "FDA rejected that request, citing a lack of data on how the drug affected young teenagers." However, two "FDA officials resigned" in 2005, after the "agency announced plans to indefinitely postpone any further review" of permitting OTC sales of Plan B. "Susan Wood, former director of the FDA's Office of Women's Health and one of the officials who resigned in 2005, thinks the changing political landscape could finally put an end to the decade-long controversy."

        Bloomberg News (4/6, Pearson, Armour) added that Korman "excoriated" the FDA for the delay in making Teva Pharmaceutical Industries' "Plan B, available over the counter. ... 'These emergency contraceptives would be among the safest drugs sold over the counter,' Korman wrote, and 'the number of 11-year-olds using these drugs is likely to be minuscule.'" FDA spokesperson Erica Jefferson "declined to comment on the ruling or the possibility of an appeal to the US Court of Appeals in New York."

        The Christian Science Monitor (4/6, Richey) said Korman, a "Reagan nominee, has presided over the Plan B litigation for years. In 2009, he ordered the Food and Drug Administration to expand availability of the drug without prescription to 17-year-olds."

        The Wall Street Journal (4/6, A3, Kendall, Anderson, Subscription Publication) reported that on Friday, Korman gave the FDA 30 days to lift the age restrictions from the Plan B emergency contraceptive and its generic equivalents. NBC News (4/6, Aleccia) in its "Vitals" blog added that Korman gave the FDA "the option of limiting the expanded access to the Plan B One-Step single-pill product if the agency 'actually believes there is any significant difference between the one- and two-pill products.'"

        The Philadelphia Inquirer (4/7, McCullough) noted that at present, the Plan B One-Step and Next Choice are "available without a prescription only to women 17 and older. The products are also kept behind the pharmacist's counter; purchasers must show a government-issued ID with proof of age."

        According to the Los Angeles Times (4/6, Morin) "Booster Shots" blog, the "ruling comes in response to a lawsuit filed by the Center for Reproductive Rights, which argued that restrictions placed on the drug imposed unreasonable delays for women of all ages" because the age prohibitions forced pharmacists to keep the products "behind counters so that they were not available outside regular business hours." US Department of Justice spokesperson Allison Price "said the government was 'reviewing the appellate options and expects to act promptly.'"

        Meanwhile, The Hill (4/5, Viebeck) "Healthwatch" blog noted that the Korman's decision "won praise from the medical community and supporters of abortion rights, who have litigated cases involving emergency contraception since 2001. 'Today science has finally prevailed over politics,' said" Center for Reproductive Rights CEO Nancy Northup.

        Similarly, CQ (4/6, Norman, Subscription Publication) said supporters "characterized the ruling as a major victory that will open the door to wider use of a safe and effective drug." Conversely, that puts "Obama and Sebelius on the side of some of the same groups that they are fighting in court over a separate requirement that all FDA-approved contraceptives - including the morning-after pill - be covered in workers' health insurance plans as preventive services under the health care law," CQ noted.

        In contrast, the Boston Globe (4/6, Kotz) reported that critics said the ruling means "young teens might indiscriminately incorrectly use the morning after pill as a method of birth control and that it might encourage sexual promiscuity. 'The decision will give young girls a serious drug,' said Anne Fox, president of the Massachusetts Citizens for Life, an antiabortion group. 'I think it's very irresponsible,'" Fox added. In the meantime, the Federal government is "expected to release its final rules for coverage of birth control methods such as oral contraception and intrauterine devices within the next few weeks."

        The ruling was also covered by the Atlantic (4/6, Hamblin), the New York Daily News (4/6, Marzulli, McShane), the New York Post (4/6, Maddux), Politico (4/6, Smith), the CNN (4/5, Landau) website, MSNBC (4/6, Cowley) on its website, the Time (4/6, Sifferlin) "Healthland" blog, the Dayton (OH) Daily News (4/6, McCarty), the Daily Caller (4/6, May), the NPR (4/6, Rovner) "Shots" blog, Reuters (4/6, Dye), BBC News (4/6), MedPage Today (4/6, Neale) and HealthDay (4/6, Reinberg).

        NYTimes: Ruling Admonishes Administration's Politically Motivated Decision. The editorial board of the New York Times (4/6, A16, Subscription Publication) opined that Korman's decision to overturn the Obama Administration's "ban preventing girls younger than 17 from purchasing emergency contraceptive" products OTC, was a "well-deserved rebuke to a politically motivated decision that overrode sound science and the health needs of young girls in order to placate political opponents of emergency contraception."

        NYSun: "Plan C" Should Deal With Parental Authority. The New York Sun (4/8) editorializes that Korman's ruling "has ignited quite an uproar" among parents on both "the right and left, including, it turns out, the President." Korman did not make it "his job to rule on the moral issues" or on "what one might call the good parenting issues," both of which are "better dealt with in the Congress or what we are sometimes prone to call 'Plan C.'" The Sun concludes that at this point, the "right move for Congress would be to reinforce the authority of the parents, who, after all, would be paying for any pills any 11 year old purchases."

        Bloomberg News: Sebelius Should Let Ruling Stand. Bloomberg News (4/5) editorialized that many physicians have "explained," that they oppose age restrictions because the morning-after products are "most effective if taken within 24 hours of unprotected sex" and quite often, there "isn't time for users to see a doctor before going to the pharmacy." In fact, Bloomberg News pointed out, "last November, the American Academy of Pediatrics recommended that its members work around the age restriction by prescribing the drug to teens in advance." The editorial also noted that several other physician groups, including the AMA, have voiced support for lifting the access restrictions on emergency contraceptives. Now, with the "presidential election that loomed" over Secretary Sebelius' "2011 action well past, she should let the judge's order stand," Bloomberg News concluded.

DIA Daily. This daily enewsletter features summaries of breaking news and information about the pharmaceutical, biotechnology, and medical device fields from thousands of global news sources. This easy-to-read enewsletter is delivered to your inbox every business morning.

Subscribe to the DIA Daily.View archives.
iPhone and iPad Apps available! Download "BulletinHC."DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org.Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044 Copyright © 2012 by BulletinHealthcare| 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191