这其间蕴含的原理和机锋，对于开展中国药品规制形成与变迁的研究，亦不失为一个有力的分析工具。正是由于“当前有些地方出现乱售伪劣药品，坑害人民，破环社会治安，对内对外影响极坏”，由于1970年代末在安徽、河南发生了一些假劣药品置人死亡的案例，使得国务院于1980年提出“健全药事法制，由卫生部牵头会同有关部门，总结国内外经验，以1978年国务院批转的《
药政管理条例》为基础，拟定‘药政法’”。[35]这促成了1984年《
中华人民共和国药品管理法》的颁布。
之后，河南省上蔡县农民白武松于1992年以限制性剧药“氯化琥珀胆碱注射液”冒充“硫酸小诺霉素注射液”和“硫酸卡那霉素注射液”，造成3名幼女死亡，1名幼女休克的严重后果。当时修订前的《
中华人民共和国刑法》对生产销售假劣药品罪的最高法定刑期间为7年，最后安徽省高级人民法院于1993年8月7日判决白武松犯以制造、销售假药的危险方法致人死亡罪，判处死刑。而正是在白武松事件发生不久，第八届全国人民代表大会常务委员会第二次会议于1993年7月2日通过了《全国人民代表大会常务委员会关于惩治生产销售伪劣商品犯罪的决定》，其中规定生产、销售假药，致人死亡或者对人体健康造成其他特别严重危害的，处十年以上有期徒刑、无期徒刑或者死刑。法定刑的提高也和灾难事件的发生有着某种程度的关联。
在2006年的岁末，前任国家药监局局长郑筱萸因利用审批权为医药企业谋求非法利益，收受非法财物折合人民币数百万元而被开除党籍，开除公职，移交司法机关处理。药品规制骤然成了传媒关注的焦点，街头巷议的热门话题。[36]温家宝总理、吴仪副总理都对药品规制给予了明确的指示，国务院也指出“政府监管部门要从郑筱萸案件中吸取教训，正确履行职责，维护好社会和公众利益。”[37]在这样的背景下，国家药监局于2007年初出台了包括向高风险企业派驻入厂监督员，启动药品再注册工作，启动对药品注册办法的修订等在内的一系列新的规制措施。
以上简略列举了我国危机时刻和药品规制改革关联的几个典型示例。今天中国药品规制或许正处于“危机时刻”，郑筱萸事件作为政治事件引发了高层领导人的关注，其间引出的药品规制问题，作为与人民利益休戚相关的民生问题，又引起了媒体和公众的关注，政治家、媒体和公众的三重关注，使得药品规制改革成为了公共议程上的优先议题。[38]但在这样的危机时刻，更需要避免去匆促出台某些缺乏论证急于求成的政策，避免去展开那些旨在“快速扭转被动局面”的形象工程，而是要倡导理性化的民主决策，从而确保规制政策形成过程的民主正当性，以及实体内容上的合法性和合理性。这或许也是美国故事所能给予的中国启示所在。
【注释】 UNITED STATES v. JOHNSON，May 29, 1911. http://www.druglibrary.org/schaffer/legal/l1910/Usvjohnson.htm。
James F. Hoge, The Drug Law in Historical Perspective, 1 Food Drug Cosm. L.Q. 48, 55 (1946).
James F. Hoge, The Drug Law in Historical Perspective, 1 Food Drug Cosm. L.Q. 48, 55-58 (1946).
Andrea F.Balis, Miracle Medicine: The Impact of Sulfa Drugs on Medicine, the Pharmaceutical Industry and Government Regulation in the U.S. in the 1930s , Dissertation for Doctor of Philosophy, City University of New York, 193(2000).
James Harvey Young, The Government and the Consumer: Evolution of Food and Drug Laws——The 1938 Food, Drug, and Cosmetic Act, 13 J.Pub.L.197, 197(1964).
David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions,6 Law & Contemp. Probs.1, 6 (1939)
Ole Sathe, Objectives of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosm. L.Q. 196 ,198(1946)
Suzanne White Junod, An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation, 55 Food & Drug L.J.161, 170(2000).
Fred B.Linton, Leaders in Food and Drug Law (Part Five), 5 Food Drug Cosm. L.Q. 771,771(1946)
Ole Sathe, Objectives of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosm. L.Q. 196 ,199(1946)
David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions,6 Law & Contemp. Probs.1, 9 (1939)
James Harvey Young, The Government and the Consumer: Evolution of Food and Drug Laws——The 1938 Food, Drug, and Cosmetic Act, 13 J.Pub.L.197, 201(1964).
Ole Sathe, A Brief Review of the Legislative History of the Federal Food, Drug, and Cosmetic Act, 3 Food Drug Cosm. L.Q. 148,149(1948)
Laurence V.Burton, What the Food Manufacturer Thinks of S. 1944, 1 Law & Contemp. Probs. 120,120 (1933).
Andrea F.Balis, Miracle Medicine: The Impact of Sulfa Drugs on Medicine, the Pharmaceutical Industry and Government Regulation in the U.S. in the 1930s , Dissertation for Doctor of Philosophy, City University of New York, 198(2000).
David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions,6 Law & Contemp. Probs.1, 12-13 (1939)
David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions,6 Law & Contemp. Probs.1, 13 (1939)
James Harvey Young, The Government and the Consumer: Evolution of Food and Drug Laws——The 1938 Food, Drug, and Cosmetic Act, 13 J.Pub.L.197, 202(1964).
Nicole Gerhart, The FDA & The FTC: An Alphabet Soup Regulating The Misbranding of Food, April 30,2002.Available at http://leda.law.harvard.edu/leda/data/501/Gerhart.pdf
Carol Ballentine, Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident, FDA Consumer Magazine, June 1981.
Carol Ballentine, Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident, FDA Consumer Magazine, June 1981.
Andrea F.Balis, Miracle Medicine: The Impact of Sulfa Drugs on Medicine, the Pharmaceutical Industry and Government Regulation in the U.S. in the 1930s , Dissertation for Doctor of Philosophy, City University of New York, 231-232(2000).
Carol Ballentine, Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident, FDA Consumer Magazine, June 1981.
Andrea F.Balis, Miracle Medicine: The Impact of Sulfa Drugs on Medicine, the Pharmaceutical Industry and Government Regulation in the U.S. in the 1930s , Dissertation for Doctor of Philosophy, City University of New York, 223(2000).
Daniel Carpenter and. Gisela Sin, Crisis and the Emergence of Regulation: The Food, Drug and Cosmetic Act of 1938，Working Paper, page 27, available at http://people.hmdc.harvard.edu/~dcarpent/crisis1938.pdf.
Ole Sathe, Objectives of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosm. L.Q. 196,200-201(1946)
Ole Sathe, Objectives of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosm. L.Q. 196,201(1946)
Andrea F.Balis, Miracle Medicine: The Impact of Sulfa Drugs on Medicine, the Pharmaceutical Industry and Government Regulation in the U.S. in the 1930s , Dissertation for Doctor of Philosophy, City University of New York, 225(2000).
Ole Sathe, Objectives of the Federal Food, Drug, and Cosmetic Act, 1 Food Drug Cosm. L.Q. 196,202-203(1946)
Ole Sathe, A Brief Review of the Legislative History of the Federal Food, Drug, and Cosmetic Act, 3 Food Drug Cosm. L.Q. 148,149(1948)
Fred B. Linton, …Its Distinguished Administrators, 1 Food Drug Cosm. L.Q. 326, 333(1946)
Barry S. Roberts and David Z. Bodenheimer, The Drug Amendments of 1962: The Anatomy of a Regulatory Failure, Ariz. St. L.J. 583 (1982).
Louise G. Baldwin & Florence Kirlin, Consumers Appraise the Food, Drug, and Cosmetic Act, 6 Law & Contemp. Probs. 144 (1939).
Daniel Carpenter and. Gisela Sin, Crisis and the Emergence of Regulation: The Food, Drug and Cosmetic Act of 1938，Working Paper, page 7, available at http://people.hmdc.harvard.edu/~dcarpent/crisis1938.pdf.
《国务院批转卫生部等单位关于加强药政管理禁止制售伪劣药品的报告》（国发1980（242）号文）。
参见马昌博、龙玉琴：《郑筱萸落马掀药监风暴 中央彻查力护用药安全》，载《南方周末》2007年2月1日；张传文：《药监整顿方向：监管好监管者自身》，载《新京报》2007年2月13日。
《温家宝主持召开国务院常务会议》，载《人民日报》2007年1月25日。
参见王绍光：《中国公共政策议程设置的模式》，载《中国社会科学》2006年第5期。
