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    自古以來(lái)，民告官就是難于上青天。許多人面對“有關(guān)部門(mén)”濫用權力時(shí)都選擇了息事寧人，正所謂是做人留一線(xiàn)，日后好相見(jiàn)。而FDA作為在美國生物醫藥領(lǐng)域負責審批藥物臨床研究和上市事宜的最高機構，在眾多生物醫藥公司看來(lái)可謂是執掌了生殺大權。

    不過(guò)，較真的日本人最近還真就把FDA告上了法庭。消息顯示，日本Otsuka Pharmaceuticals公司最近在美國聯(lián)邦地方****FDA濫用監管權，損害了旗下Abilify的市場(chǎng)權益，最終決定和FDA對簿公堂。

    說(shuō)來(lái)這一案件也夠離奇，一般而言，對于生物醫藥公司來(lái)說(shuō)，當他們的藥物上市時(shí)候，為了擴大銷(xiāo)量唯恐FDA所批準的適應癥不夠多，覆蓋的患者群體不夠廣。而在這起案件中，Otsuka Pharmaceuticals卻希望這一藥物的適用癥范圍盡可能限制在一定人群中。

    原來(lái)，此次雙方面臨的焦點(diǎn)在于Otsuka公司開(kāi)發(fā)的Abilify此前被批準應用于治療妥瑞癥、躁郁癥以及精神分裂癥。這種藥物已經(jīng)上市，就為Otsuka公司帶來(lái)超過(guò)650萬(wàn)美元的收入。不過(guò)相關(guān)資料顯示，Abilify將于今年四月20日失去專(zhuān)利保護，并將面臨仿制藥的挑戰。可以預想，Abilify的銷(xiāo)售額必將大受影響。

    不過(guò)，Otsuka公司并不希望輕易放棄公司的這棵搖錢(qián)樹(shù)。Otsuka公司表示由于A(yíng)bilify此前是作為罕見(jiàn)疾病妥瑞癥的治療方案申請上市的，因此Abilify應當享受孤兒藥所具有的一切優(yōu)惠措施。這就意味著(zhù)Abilify的排他性經(jīng)營(yíng)權將再延長(cháng)7年之久。

    然而，FDA卻于最近將Abilify的適用范圍擴大至圖雷特綜合征（Tourette syndrome ,TS是一種相對普通的神經(jīng)紊亂，特征是無(wú)意識地快速抽搐，突然移動(dòng)，或者發(fā)出聲音，并且以相同的方式重復）的治療，根據相關(guān)規定，這也意味著(zhù)Abilify將無(wú)法獲得延長(cháng)的排他性經(jīng)營(yíng)權。

    Otsuka公司**FDA在缺乏相關(guān)臨床數據的基礎上，未能充分考慮到Abilify對圖雷特綜合征患者的安全性和有效性等方面就做出了這一決定，涉及濫用其審批權利，因而請求**駁回FDA的這一決定。（小編想問(wèn)一句，是不是你們拿錯劇本了？）Otsuka公司與FDA的這一爭執目前為止尚屬罕見(jiàn)。不過(guò)，無(wú)論結果如何，小編竊以為這樣的做法必將有利于規范生物醫藥企業(yè)以及醫藥管理機構雙方的行為規范。這種不畏公共權力，敢于一切從法律角度出發(fā)和行政部門(mén)“叫板”的精神值得國內的管理機構和醫藥行業(yè)從業(yè)者學(xué)習。（生物谷Bioon.com）詳細英文報道：

    Japan's Otsuka Pharmaceuticals accused the U.S. FDA in a unique court suit of manipulating its regulatory procedures to kill off its 7-year exclusivity to market Abilify （a**iprazole） for treating Tourette syndrome in children.

    Under normal circumstances, a drugmaker wants as broad an indication or as many of them as possible to widen the scope of possible sales. In this case, Otsuka wants to keep its narrow, pediatric indication.

    Otsuka filed the suit in a federal district court, which could issue an injunction soon, seeking to reverse the FDA's action, which the Japan-based company called “arbitrary, capricious and unlawful abuse of its authority.” Up to $45.5 million could be hanging on the suit's outcome.

    Otsuka obtained 7-year exclusivity to market Abilify in December under the FDA's orphan drug procedures, based on the Tourette pediatric indication. Up to now, Abilify had been earning Otsuka $6.5 million a year as one of the leading antipsychotic drugs, including treatment for bipolar disorder and schizophrenia.

    In an almost Kafkaesque twist and why Otsuka is upset, Abilify's patent protection is set to expire April 20, opening it to generic competition. The orphan drug approval for treating Tourette's was Otsuka's way of keeping Abilify on the market as well as its new indication for an additional 7 years without a generic challenge.

    That is what Otsuka saw as the drug's near future until February, when the agency added what Otsuka might consider a Machiavellian twist. Apparently, the FDA stepped in and decided to lift the restriction of the new indication to pediatric use and give it a new indication for treating Tourette's at all ages. That had the effect, Otsuka argued in its suit, of eliminating the 7-year exclusivity intended for pediatric use, and thus opening that indication to generic competition next month.

    The argument Otsuka laid out in the suit and what the court must determine is whether the agency can approve Abilify for a broader segment of the population when no clinical trials have been conducted to test its safety and effectiveness in treating Tourette's in those age groups.