美國藥事法
U.S. Pharmaceutical Law
| 節 | 週二 |
|---|---|
5 13:20–14:10 | 美國藥事法 ES806 2 節連堂 |
6 14:20–15:10 |
* 根據陽明交大上課時間表所列
Social Background and Importance of the Issue The dramatic development of biotechnology brought explosion of the number of drugs and necessarily changed medicine. It has become inevitable for physicians to acquire and understand the information on drugs and to apply the information to each patient according to his/ her individual medical conditions. Furthermore, the development of pharmaceutical industry not only brought new medicines for waiting patients but also cause problems because of the active promotion of drugs toward physicians. In addition to that, in the case of outpatient, since patients take drugs out of the supervision of physicians, physicians’ explanation to patients and patients’ independent action become important. Because of this social background, rules which had mainly focused on regulating physician-patient relationship have changed to a complexed network of rules which regulate not only distribution of drugs as items but also the flow of drug information. In the U.S., in order to achieve the goal of the safety of drugs, administrative laws, civil laws, and industrial/ medical self-regulations have created a system where rules promote the appropriateness of information itself and also promote each actors related to medication to communicate each other in order to prevent errors in conveyance and application of information for the goal of safe and effective medication. To achieve the safety of drugs is an important and urgent issue in Taiwan as well. It is necessary to learn how the U.S. has developed the legal system not only for the students who work in the international medical industry but also for the students to be policy makers, legal practitioners and medical professionals who will shape the system in Taiwan. Course Goals In this course, students will be introduced the laws and regulations which consist a legal system for safe medication in the United States. The course starts from the introduction of the establishment of federal pharmaceutical law and states’ product liability law. Then, it will turn to the current federal administrative regulations of new drugs pre and post marketing. It also looks at the issue of preemption of federal administrative regulations over states’ product liability law. The course then turns to the promotional activities of pharmaceutical companies towards physicians and regulatory challenge for the government. With regard to the prescription drugs, though the central target of the regulation had been the industry and physicians, the concern for the information delivery to the patients has become huge issue. Thus, course focuses on information delivery to patients not only from physicians but also from administrators and pharmacists. Through learning each issues, students will learn how federal statutes (Food, Drug and Cosmetic Act and other related laws), administrative regulations, product liability law and tort law interact and have shaped a network of laws for the appropriateness of drug information and its communication. At the end of the class, students will know the legal system surrounding drugs in the U.S. and will be able to analyze how and for which issues laws in Taiwan could be improved.
Language This is an English-taught course. Students also need to discuss on issues and cases in English. Therefore, sufficient English ability is necessary. Prior Study A prior tort law and/ or product liability law course/ study is recommended but not required. Student Background This class expects the diversity of student background in order to have more interaction of different background, practical experience and academic area. Students from different school, medical professionals (such as physicians, pharmacists and nurse), medical industry, and legal practitioners are welcome to take this class.
The grade would be evaluated through the following ways: 1. Attendance 20% 2. Participation and performance in class discussion 30% (including group debate & individual presentation of case briefs) 3. Written final examination. 50% Participation for on-line student (synchronous classes) The students could summit the class report or questions on Internet. The class participation and attendance policy is the same with physical class students. Participation for on-line student (asynchronous classes) Students should submit at least 5 case briefs by the end of the semester.
- U.S. Pharmaceutical Law
| 週次 | 主題 |
|---|---|
| 第 1 週 | Course Introduction Evolution of drug law in the first 20th century |
| 第 2 週 | Definition of drug Drug approval process Squibb v. Bowen, 870 F.2d 678 (D.C.Cir. 1989) Labeling Kordel v. U.S., 335 U.S. 345 (1948) |
| 第 3 週 | Access to drugs 1) Accelerating approval process 2) Expanding access to investigational drugs Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C.Cir. 2007) |
| 第 4 週 | Regulation on the Controlled Substances Raich v. Gonzales, 125 S.Ct. 2195 (2005) Drugs for Rare Diseases and Pediatrics |
| 第 5 週 | Post-market surveillance 1) Reporting system 2) Regulatory actions Forsham v. Califano, 442 F.Supp. 203 (D.D.C. 1977) 2) Use of Big Data for Active Surveillance |
| 第 6 週 | Product liability law as applied to drugs 1) PL law preliminary 2) Application to drugs 3) Duty to warn and learned intermediary doctrine Sterling Drug Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966) Tort claims against FDA Galley v. Astra Pharmaceutical Products, Inc., 466 F.Supp. 182 (D.Minn. 1979) |
| 第 7 週 | Product Liability law and FDCA labeling regulation 1) Post-market duty to warn under PL law 2) Federal preemption Wyeth v. Levine, 129 S. Ct. 1187 (2009) Pliva v. Mensing, 131 S. Ct. 2567 (2011) |
| 第 8 週 | Promotion to physicians- Industrial influence 1) Various promotional activities 2) Conflict of Interest of Physicians 3) Limitation of Regulations under FDCA on Promotional Activities 4) Duty to warn- over promotion Brown v. Glaxo, Inc., 790 So.2d 35 (La.App. 2000) Formella v. Ciba-Geigy Corp., 300 N.W.2d 356 (Mich. Ct. App. 1980) |
| 第 9 週 | Promotion to physicians- Regulation of gifting 1) Federal Anti-kickback Statute 2) Federal False Claims Act U. S. ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39 (D. Mass. 2001) 3) Industrial/ Professional Self-regulations 4) Disclosure Laws |
| 第 10 週 | Promotion to physicians- Off-Label use and its promotion Group Debate Wash. Legal Found. v. Friedman, 13 F. Supp. 2d. 51 (D.D.C. 1998) United States v. Caronia, 703 F.3d 149 (2nd Cir. 2012) |
| 第 11 週 | Commercial Speech and pharmaceutical promotion 1) Development of commercial speech doctrine 2) Data Mining Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011) |
| 第 12 週 | Information to Patients 1) Development of Patient labeling 2) Informed Consent Doctrine under Tort law 3) Challenges against Learned Intermediary Doctrine MacDonald v. Ortho Pharmaceutical Corp., 475 N.E.2d 65 (Mass. 1985) Reaves v. Ortho Pharm. Corp., 765 F.Supp. 1287 (E.D.Mich. 1991) |
| 第 13 週 | Pharmacist Role and Responsibility 1) State Regulation of Pharmacist 2) Emergence of federal Regulation of Pharmacist 3) Pharmacists’ duty under tort law Adkins v. Mong, 425 N.W.2d 151 (Mich. Ct. Spp. 1988) Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118 (Ill.2002) Horner v. Spalitto, 1 S.W.3d 519 (Mo. Ct. App. 1999) |
| 第 14 週 | Direct-to-consumer advertisement 1) Pros and Cons 2) Learned Intermediary Doctrine in DTCA context Perez v. Wyeth Lab. Inc., 734 A.2d 1245 (N.J. 1999) Watts v. Medicis Pharm. Corp., 365 P.3d 944 (Ariz. 2016) |
| 第 15 週 | Drug pricing Vermont v. Leavitt, F.Supp.2d (D.Vt.2005) OTC switch & Regulation on OTC drug |
| 第 16 週 | Hatch-Waxman Act and Generic Drugs Lecture by Prof. Thomas Chih-hsiung Chen (date is TBD) |
| 第 17 週 | Course wrap up |
| 第 18 週 | Final Exam |
Cases and articles for each issue will be distributed in the classes.
- 地點
- Professor’s office 電子資訊中心628
- 時間
- 16:00-18:00 Every Tuesday
- 聯絡方式
- Please send email and make appointment naokoakimoto@nctu.edu.tw