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

    不過，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(jiān)管權(quán)，損害了旗下Abilify的市場權(quán)益，最終決定和FDA對簿公堂。

    說來這一案件也夠離奇，一般而言，對于生物醫(yī)藥公司來說，當(dāng)他們的藥物上市時候，為了擴(kuò)大銷量唯恐FDA所批準(zhǔn)的適應(yīng)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，此次雙方面臨的焦點在于Otsuka公司開發(fā)的Abilify此前被批準(zhǔn)應(yīng)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公司帶來超過650萬美元的收入。不過相關(guān)資料顯示，Abilify將于今年四月20日失去專利保護(hù)，并將面臨仿制藥的挑戰(zhàn)。可以預(yù)想，Abilify的銷售額必將大受影響。

    不過，Otsuka公司并不希望輕易放棄公司的這棵搖錢樹。Otsuka公司表示由于Abilify此前是作為罕見疾病妥瑞癥的治療方案申請上市的，因此Abilify應(yīng)當(dāng)享受孤兒藥所具有的一切優(yōu)惠措施。這就意味著Abilify的排他性經(jīng)營權(quán)將再延長7年之久。

    然而，F(xiàn)DA卻于最近將Abilify的適用范圍擴(kuò)大至圖雷特綜合征（Tourette syndrome ,TS是一種相對普通的神經(jīng)紊亂，特征是無意識地快速抽搐，突然移動，或者發(fā)出聲音，并且以相同的方式重復(fù)）的治療，根據(jù)相關(guān)規(guī)定，這也意味著Abilify將無法獲得延長的排他性經(jīng)營權(quán)。

    Otsuka公司**FDA在缺乏相關(guān)臨床數(shù)據(jù)的基礎(chǔ)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(quán)利，因而請求**駁回FDA的這一決定。（小編想問一句，是不是你們拿錯劇本了？）Otsuka公司與FDA的這一爭執(zhí)目前為止尚屬罕見。不過，無論結(jié)果如何，小編竊以為這樣的做法必將有利于規(guī)范生物醫(yī)藥企業(yè)以及醫(yī)藥管理機(jī)構(gòu)雙方的行為規(guī)范。這種不畏公共權(quán)力，敢于一切從法律角度出發(fā)和行政部門“叫板”的精神值得國內(nèi)的管理機(jī)構(gòu)和醫(yī)藥行業(yè)從業(yè)者學(xué)習(xí)。（生物谷Bioon.com）詳細(xì)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.