美國抗憂鬱藥物增加自殺風險之黑盒警示合憲性探討──以美國法為中心【醫法新論】 試閱
The Constitutional Study on U.S. Black Box Warning of Antidepressants Increasing the Risk of Suicides： In Terms of United States Perspective
美國食品藥物管理局在2004年對抗憂鬱藥物發布黑盒警示後，造成社會上相當大的討論，質疑該黑盒警示之必要性。按黑盒警示本身為強制性商業言論之一種，據此，本文第一部分先介紹美國聯邦最高法院對商業性言論之審查基準，故以Central Hudson Gas &Electric Corp. v. Public Service Commission乙案，介紹美國聯邦法院審查商業性言論所適用之四部分檢驗，再以Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio乙案，介紹美國聯邦法院就強制性言論之憲法審查基準。第二部分，回歸本文所主要討論抗憂鬱藥物之黑盒警示是否過度限制抗憂鬱藥物廠商受美國憲法第一修正案所保護之權利，故先討論是否適用Zauderer案之審查基準，若不適用，則應適用Central Hudson案之審查基準。最後，本文就美國食品藥物管理局針對抗憂鬱藥物所發布之黑盒警示給予一些回饋及未來展望。
After the FDA issued a black box warning against antidepressants in 2004, it caused considerable discussion in the society and questioned the need for the black box warning. The black box warning is a type of compelled commercial speech. Regarding this, the first part of this article is to introduce the Supreme Court of the United States’ constitutional review of commercial speech. In Central Hudson Gas & Electric Corp. v. Public Service Commission, the court build the four-part test applied in the constitutional review of commercial speech by Supreme Court of the United States. Then I introduce the Constitutional Review Benchmark of the Supreme Court of the United States for compelled speech in Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio. In the second part, back to the issue this article mainly discusses, which is whether the black box warning of antidepressant excessively restricts the rights of antidepressant drug manufacturers protected by the First Amendment of Constitution of the United States, it begins at discussing whether the constitutional review of Zauderer case is applicable, if not, the constitutional review of Central Hudson case shall be applied. In the last part, this article gives some feedback and prospect of the black box warning issued by FDA for antidepressants.
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