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Volumn 20, Issue 2, 2008, Pages 135-144

'Off-label' drug use: An FDA regulatory term, not a negative implication of its medical use

Author keywords

Doctor; Duty; FDA; Informed consent; Learned Intermediary Doctrine; Off label; Physician; Standard of care

Indexed keywords

CLINICAL DECISION MAKING; CLINICAL PRACTICE; COURT; DRUG APPROVAL; DRUG LABELING; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; INFORMED CONSENT; INTERPERSONAL COMMUNICATION; LAW SUIT; MEDICAL LIABILITY; OFF LABEL DRUG USE; PATIENT CARE; PATIENT INFORMATION; PHYSICIAN; PHYSICIAN ATTITUDE; PRESCRIPTION; PRIORITY JOURNAL; REVIEW;

EID: 40649090924     PISSN: 09559930     EISSN: 14765489     Source Type: Journal    
DOI: 10.1038/sj.ijir.3901619     Document Type: Review
Times cited : (25)

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    • Broderick v. Sofamor Danek Group, Inc., No. 95-8644-CIV-RYSKAMP, 1999 WL 1062135, at *3 (S.D.Fla. April 09, 1999), citing Upjohn Co. v. MacMurdo, 562 So.2d 680, 681 (Sup.Ct.Fla. 1990).
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    • Relkin, supra note 90, at 231, quoting Greiner v. Sofamor, 1999 U.S. Dist. LEXIS 4484, *16 (D. Minn. March 08, 1999), quoting Brooks v. Medtronic Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).
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    • supra note 1, at 524, citing Davis v. Wyeth Laboratories Inc
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    • (1968) 399 F.2d 121 (9th Cir
    • Endejann1
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    • Endejann, supra note 1, at 524, citing Stephens v. G.D. Searle & Co., 602 F.Supp. 379 (E.D.Mich. 1985); Odgers v. Ortho Pharm. Corp., 609 F.Supp. 867 (E.D.Mich. 1985). 'However, most jurisdictions decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson v. Searle & Co., 775 F. Supp 417 (D.D.C. 1991); Reaves v. Ortho Pharm. Corp., 765 F.Suppl. 1287 (E.D.Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F.Suppl. 1511 (S.D.Fla. 1990).
    • Endejann, supra note 1, at 524, citing Stephens v. G.D. Searle & Co., 602 F.Supp. 379 (E.D.Mich. 1985); Odgers v. Ortho Pharm. Corp., 609 F.Supp. 867 (E.D.Mich. 1985). 'However, most jurisdictions decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson v. Searle & Co., 775 F. Supp 417 (D.D.C. 1991); Reaves v. Ortho Pharm. Corp., 765 F.Suppl. 1287 (E.D.Mich. 1991); Zanzuri v. G.D. Searle & Co., 748 F.Suppl. 1511 (S.D.Fla. 1990).
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    • Endejann, supra note 1, at 524. Jurisdictions are split over whether the FDA-Mandate exception precludes the use of the learned intermediary doctrine. See Endejann, supra note 1, at 524 n.200. Further, 'most jurisdictions, however, decline to recognize a contraceptive exception.' Endejann, supra note 1, at 524 n.199, citing MacPherson, 775 F.Suppl. 417; Reaves, 765 F.Suppl. 1287; Zanzuri, 748 F.Suppl. 1511.
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    • Broderick, 1999 WL 1062135 at *3, citing Barrow v. Bristol-Meyers Squibb, Co., No. 96-689-CIV-ORL-19B, 1998 WL 812318 (M.D.Fla. 1998).
    • Broderick, 1999 WL 1062135 at *3, citing Barrow v. Bristol-Meyers Squibb, Co., No. 96-689-CIV-ORL-19B, 1998 WL 812318 (M.D.Fla. 1998).
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    • Davenport v. Medtronic, Inc., 302 F.Supp.2d 419, 440 (E.D.Pa. 2004), citing Little v. Depuy Motech Inc., No. 96CV0393-L JAH, 2000 WL 1519962, at *9 (S.D.Cal. June 13, 2000); Cox v. Depuy Motech Inc., No. 95-3838, 2000 WL 1160486, at *8-9 (S.D.Cal. March 29, 2000).
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    • Farley & Waters, supra note 103, at 1, citing United States v. Parke-Davis, 147 F.Supp.2d 39, 44 (D.Mass. 2001, quoting Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001).
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    • Beck & Azari, supra note 4, at 79, quoting United States General Accounting Office, Report to the Chairman, Committee on Labor and Human Resources, U.S. Senate, Off-Label Drugs: Reimbursement Policies Constrain Physicians in their Choice of Cancer Therapies 11 (1991).
    • Beck & Azari, supra note 4, at 79, quoting United States General Accounting Office, Report to the Chairman, Committee on Labor and Human Resources, U.S. Senate, Off-Label Drugs: Reimbursement Policies Constrain Physicians in their Choice of Cancer Therapies 11 (1991).
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    • Beck & Azari, supra note 4, at 79, quoting Promotion of Drugs and Medical Devices for Unapproved Uses: Hearing Before the Human Resources and Intergovernmental Relations Subcomm. of the House Comm. on Gov't Operations, 102d Cong., 1st Sess. 103 (1991) (statement of George Lundberg, M.D.).
    • Beck & Azari, supra note 4, at 79, quoting Promotion of Drugs and Medical Devices for Unapproved Uses: Hearing Before the Human Resources and Intergovernmental Relations Subcomm. of the House Comm. on Gov't Operations, 102d Cong., 1st Sess. 103 (1991) (statement of George Lundberg, M.D.).
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  • 105
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    • Hixson, supra note 79, at 214-215.
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  • 107
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    • Fox, supra note 27, at 1166, citing Off-Label Drug Use and FDA Review of Supplemental Drug Applications, Hearing Before the Subcomm. on Human Resources and Intergovernmental Relations of the H. Comm. on Government Reform and Oversight, 104th Cong. 1 (1996) (statement of Abbey S. Meyers, President, Nat'l Org. of Rare Disorders).
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    • Stoffelmayr, supra note 17, at 278, citing United States General Accounting Office, Pub No GAO/PEMD-91-14, Off-Label Drugs: Reimbursement Policies Constrain Physicians in Their Choice of Cancer Therapies 22, 25 (1991).
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    • Hixson, supra note 79, at 213, citing Gregory Hazard, Please, Sir, I Want Some More: Congress' Carrot-and-Stick Approach to Pediatric Testing Leaves Therapeutic Orphans Needing More Protection, 20 J. Contemp. Health L. & Pol'y 467, 478 (2004).
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    • Fox1
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    • Richardson, 44 S.W.3d at 8.
  • 159
    • 40649128780 scopus 로고    scopus 로고
    • Richardson, 44 S.W.3d at 17.
    • Richardson, 44 S.W.3d at 17.
  • 160
    • 40649125566 scopus 로고    scopus 로고
    • Richardson, 44 S.W.3d at 22.
    • Richardson, 44 S.W.3d at 22.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.