╨╧рб▒с>■  35■   2                                                                                                                                                                                                                                                                                                                                                                                                                                                ье┴` Ё┐0░bjbjцЗцЗ ."ДэДэ░      диииииии╝DDDD P ╝h~~~~~~~ЪЬЬЬЬЬЬ$) hС Ж└и╕~~╕╕└ии~~╒RRR╕vи~и~ЪR╕ЪRRииR~\ а╪Б√gH╞D. RЪы0R 8 RR иf4~аrRР\ь╠~~~└└H ~~~╕╕╕╕╝╝╝d $╝╝╝ ╝╝╝ииииии     Press Release from WisPolitics.comAG Lautenschlager: Seeks to Join Lawsuit Against FDA over Delay in "Plan B" Emergency Contraception 3/15/2006 Contact: Kelly Kennedy 608/266-7876 MADISON - Attorney General Peg Lautenschlager announced today she has asked a federal district court judge in New York to allow the State of Wisconsin to intervene, as a plaintiff, in a lawsuit filed by the Center for Reproductive Rights challenging the federal Food and Drug AdministrationТs (FDAТs) refusal to move a form of emergency conception pills, УPlan B,Ф to over-the-counter status. In December, Lautenschlager received Governor Jim DoyleТs permission to work with his office in investigating the impact of the FDAТs actions on the State of Wisconsin. Yesterday, the Governor gave his approval to file the action against the FDA. The Attorney GeneralТs actions will seek to have the State of Wisconsin named as a plaintiff in the New York lawsuit which is now in the discovery phase before U.S. District Court Judge Edward Korman. In that lawsuit (Tummino, et. al. v. Andrew C. Von Eschenbach) filed in January 2005, the judge denied FDAТs preliminary motions to end the case and, in a significant ruling in February, has allowed the current plaintiffs to take depositions of high-level FDA officials. The judge has discretion over whether to allow the State of Wisconsin to intervene as a plaintiff, and Lautenschlager has filed papers giving the court reasons why that should be allowed. The complaint against the FDA details the interests of Wisconsin and alleges that relevant, peer-reviewed scientific literature long ago confirmed that emergency contraception pills should have been moved by FDA to over-the-counter status. УThe citizens of Wisconsin who are being harmed by this politically motivated delay deserve answers, and they deserve action,Ф Lautenschlager said. УThe negative effects of withholding approval of this drug over political -- not scientific or other legitimately accepted grounds -- are far reaching, hurting not only victims of rape who might be in need of emergency contraception, but the greater community health, the economy and the fundamental right to justice.Ф Lautenschlager has been a long-time advocate of contraceptive equity and reproductive rights, issuing landmark opinions on the subject as Attorney General (see  HYPERLINK "http://www.doj.state.wi.us" www.doj.state.wi.us). Background: Plan B prevents pregnancy from occurring and is not a drug used to terminate a pregnancy. Plan B has been available by prescription since 1999. In 2003, the FDA was asked to review making Plan B available without a prescription. After several delays in issuing a decision, the FDA again postponed a ruling in August 2005, leading to the resignation of high-level FDA officials who believed Plan B should be made available over-the-counter. A report released in November 2005, by the United States Government Accountability Office (GAO) stated that the FDA departed from its own policies in how it handled Plan BТs market status. The GAO, an independent, nonpartisan УwatchdogФ agency that investigates for Congress how the federal government spends taxpayer dollars found in its report four aspects of the FDAТs Plan B process that it called УunusualФ: FDA directors of the offices that reviewed Plan BТs application, who would normally have been responsible for signing off on any decision on over-the-counter status of a drug, refused to sign the non-approval letter because they disagreed with the decision. FDAТs high-level management was more involved in the review of Plan B than those of other over-the-counter applications. There was evidence suggesting the decision not to approve the application was made even before reviews of the application had been completed. The FDAТs reasoning for postponing approval Ц that there would be implications for adolescents under the age of 14 Ц was УnovelФ and Уdid not follow FDAТs traditional practices.Ф The GAOТs report showed that the procedure and reasoning behind the FDAТs 2004 postponement on Plan B was unprecedented. According to the report, of the 67 over-the-counter proposals between 1994 and 2004, Plan B was the only proposal the FDA refused to approve, after the agencyТs own advisory committees recommended approval. Plan B, manufactured by Barr Laboratories, Inc., contains a higher dose of the same hormone used in standard birth-control pills. If taken within 72 hours of unprotected sex, Plan B can be effective in preventing pregnancy. It is most effective if taken within 24 hours, however. This short timeline to take the drug, along with its effectiveness and safety record, are the primary reasons advocates support making it available over-the-counter.$ЗЛ й <=efyzНп░ъ╥╟╣╟й╟йЬй╟╣╟Шh*!└h{Еh{Е>*B*ph jh{Еh{ЕB*Uphh{Еh{Е5БB*\Бphh{Еh{ЕB*ph/h{Еh{Е5БB*CJOJQJ\Б^JaJph)h{Е5БB*CJOJQJ\Б^JaJph#$░¤¤¤░¤,1Рh░╨/ ░р=!░"░#Ра$Ра%░░╨░╨ Р╨ЖЬD@ё D NormalCJ_HaJmH nHsH tHDA@Є бD Default Paragraph FontRi@є │R  Table NormalЎ4╓ l4╓aЎ (k@Ї ┴(No List░ "    #$▓Ш0ААШ0ААШ0АА▓ 00&░░░< e y ░X М   r dX∙s T╡t мчu ЇV∙v ╝_∙w №>оx $╦y ьл╡z Мл{ Дм╡| Д√хх~ддTT╪╪▓  ююЗмм]]сс▓ 9 *Аurn:schemas-microsoft-com:office:smarttagsАStateА9 *Аurn:schemas-microsoft-com:office:smarttagsАplaceА ─ї '5█щTb!<FНFTЬк▓▓#▓▓нhjх;J"Р(т\Д{Е─,п*!└>2╧ @А╗╗╗щ╗╗@Д└{░Р@  Unknown            GРЗz А Times New Roman5РАSymbol3&Р Зz А ArialWРЖSimSunArial Unicode MS"qИЁ╨hд{гfж{гf╩ц !╩ц !!Ёа┤┤ББr4зз2ГQЁHX)Ё ?ф                     {Е2  Press Release from WisPoliticslisawynnlisawynn■ рЕЯЄ∙OhлС+'│┘0РРШ└╠рь°  , L XdpxАИф Press Release from WisPolitics lisawynn Normal.dot lisawynn1Microsoft Office Word@МЖG@Р░gH╞@бўgH╞╩ц■ ╒═╒Ь.УЧ+,∙оD╒═╒Ь.УЧ+,∙о` hpРШаи ░╕└╚╨ √фPrinceton University! з Press Release from WisPolitics Title╕ 8@ _PID_HLINKSфAp#xhttp://www.doj.state.wi.us/▄ ■   ■    !■   #$%&'()■   +,-./01■   ¤   4■   ■   ■                                                                                                                                                                                                                                                                                                       Root Entry         └FРuЛ√gH╞6АData             1Table    WordDocument    ."SummaryInformation(            "DocumentSummaryInformation8        *CompObj            q            ■                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           ■       └FMicrosoft Office Word Document MSWordDocWord.Document.8Ї9▓q