The regulation of prescription drug promotion

Ethics and the Pharmaceutical Industry

Volumn , Issue , 2005, Pages 153-168

  Abrams, Thomas ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

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[No Author keywords available]

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EID: 65949086849     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1017/CBO9780511610769.015     Document Type: Chapter

References (16)

1. IMS Health, IMS National Sales Perspectives, 2003, data extracted August 2004.
2. IMS Health, Integrated Promotional Services: Total Promotion Report. 3.
3. Fed. Reg. 3126, December 28, 1938.
4. Aikin KJ, Swasy JL, and Braman AC, “Patient and Physician Attitudes and Behaviors AssociatedWith Direct-to-Consumer Promotion of Prescription Drugs: Summary of FDA Survey Research Results. Final Report,” Center for Drug Evaluation and Research, Food and Drug Administration, Technical research report, 2004.
5. IMS Health, Integrated Promotional Services: Total Promotion Report. These percentages are based upon calculations by the Division of Drug Marketing, Advertising, and Communications at the Food and Drug Administration.
6. IMS Health, Integrated Promotional Services: Integrated Share of Voice Report. These percentages are based upon calculations by the Division of Drug Marketing, Advertising, and Communications at the Food and Drug Administration.
7. IMS Health, Integrated Promotional Services: Total Sampling Report.
8. CFR §314.81(b)(3)(i).
9. Section 502(n)(3)(A); 21 U.S.C. §352(n)(3)(A).
10. Further information about these and other letters is available at www.fda.gov/cder/warn/index.htm Accessed May 25, 2005.
11. CFR Parts 314.500 & 314.600.
12. CFR §601.40 et seq.
13. CFR §§314.550; 314.640; 601.45.
14. CFR §202.1(j)(4).
15. Available at www.fda.gov/cder/guidance/5669dft.pdf Accessed May 25, 2005.
16. Available at www.fda.gov/cder/guidance/6019dft.pdf Accessed May 25, 2005.