The promotion of medical products in the 21st century: Off-label marketing and first amendment concerns

JAMA - Journal of the American Medical Association

Volumn 314, Issue 17, 2015, Pages 1795-1796

  Sharfstein, Joshua M ^a   Charo, Alta ^b  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^b UNIVERSITY OF WISCONSIN LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FISH OIL; ICOSAPENTAENOIC ACID ETHYL ESTER; NEUROLEPTIC AGENT; SULFANILAMIDE; THALIDOMIDE; TRIACYLGLYCEROL; ANTILIPEMIC AGENT; ETHYL EICOSAPENTAENOIC ACID; ICOSAPENTAENOIC ACID;

CARDIOVASCULAR DISEASE; CAUSE OF DEATH; CONGENITAL MALFORMATION; DECISION MAKING; DOCTOR PATIENT RELATION; DRUG APPROVAL; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEALTH PROMOTION; HUMAN; LAW; OFF LABEL DRUG USE; PRESCRIPTION; PRIORITY JOURNAL; PUBLIC HEALTH; RISK FACTOR; RISK REDUCTION; SHORT SURVEY; UNITED STATES; ADVERTIZING; ANALOGS AND DERIVATIVES; DRUG LEGISLATION; LEGISLATION AND JURISPRUDENCE;

ADVERTISING AS TOPIC; DRUG INDUSTRY; EICOSAPENTAENOIC ACID; HYPOLIPIDEMIC AGENTS; LEGISLATION AS TOPIC; LEGISLATION, DRUG; OFF-LABEL USE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84946071231     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2015.12045     Document Type: Short Survey

References (7)

1. Amarin Pharma Inc v United States Food & Drug Administration. 1:15-03588-PA (SD NY filed August 7, 2015).
2. Food and Drug Administration. Summary minutes of the Endocrinologic and Metabolic Drugs Advisory Committee meeting; October 16, 2013; Silver Spring, Maryland. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMat erials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM378970.pdf. Accessed August 31, 2015.
3. Drug efficacy study: final report to the commissioner of Food and Drugs, Food and Drug Administration, from the Division of Medical Sciences, National Research Council.Washington, DC: National Academy of Sciences; 1969.
4. Sorrell v IMS Health Inc. 131 S Ct 2653 (2011).
5. United States v Caronia. 703 F3rd 149 2nd Cir (2012).
6. Kesselheim AS, Mello MM. Prospects for regulation of off-label drug promotion. In: Lynch HF, Cohen IG, eds. FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies. New York, NY: Columbia University Press; 2015:184-203.
7. Sharfstein J. Public health and the First Amendment. Milbank Q. 2015;93(3):459-462.