Pharmacogenomics in the assessment of therapeutic risks versus benefits: Inside the United States Food and Drug Administration

Pharmacotherapy

Volumn 31, Issue 8, 2011, Pages 729-735

  Zineh, Issam ^a   Pacanowski, Michael A ^a  

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

Author keywords

Drug development; FDA; Pharmacogenetics; Pharmacogenomics; United States Food and Drug Administration

Indexed keywords

DRUG;

CLINICAL DECISION MAKING; CLINICAL PRACTICE; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG LABELING; DRUG RESPONSE; ENDOPHENOTYPE; FOOD AND DRUG ADMINISTRATION; GENETIC HETEROGENEITY; GENETIC VARIABILITY; HUMAN; PHARMACODYNAMICS; PHARMACOGENOMICS; QT PROLONGATION; REVIEW; RISK BENEFIT ANALYSIS; TREATMENT FAILURE; TREATMENT RESPONSE; UNITED STATES;

DRUG DESIGN; DRUG LABELING; HUMANS; PHARMACEUTICAL PREPARATIONS; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79961101962     PISSN: 02770008     EISSN: None     Source Type: Journal    
DOI: 10.1592/phco.31.8.729     Document Type: Review

References (17)

1. International Conference on Harmonisation. guidance on E15 pharmacogenomics definitions and sample coding. Fed Regist 2008;73:19074-6.
2. Lesko LJ, Zineh I. DNA, drugs and chariots: on a decade of pharmacogenomics at the US FDA. Pharmacogenomics 2010;11:507-12.
3. Spear BB, Heath-Chiozzi M, Huff J. Clinical application of pharmacogenetics. Trends Mol Med 2001;7:201-4. (Pubitemid 32822891)
4. Zineh I, Johnson JA. Pharmacogenetics of chronic cardiovascular drugs: applications and implications. Expert Opin Pharmacother 2006;7:1417-27. (Pubitemid 44177267)
5. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004;3:711-15. (Pubitemid 39173511)
6. Hughes B. 2009 FDA drug approvals. Nat Rev Drug Discov 2010;9:89-92.
7. Karapetis CS, Khambata-Ford S, Jonker DJ, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008;359:1757-65.
8. Mega JL, Close SL, Wiviott SD, et al. Cytochrome P450 genetic polymorphisms and the response to prasugrel: relationship to pharmacokinetic, pharmacodynamic, and clinical outcomes. Circulation 2009;119:2553-60.
9. Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med 2008;358:568-79. (Pubitemid 351214284)
10. Zineh I, Woodcock J. The clinical pharmacogeneticist: an emerging regulatory scientist at the US Food and Drug Administration. Hum genomics 2010;4:221-5.
11. U.S. Food and Drug Administration. Code of federal regulations title 21: food and drugs. Revised as of April 1, 2010. Available from http://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.56. Accessed April 1, 2011.
12. Frueh FW, Amur S, Mummaneni P, et al. Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug administration: prevalence of related drug use. Pharmacotherapy 2008;28:992-8.
13. Zineh I, Gerhard T, Aquilante CL, Beitelshees AL, Beasley BN, Hartzema AG. Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J 2004;4:354-8. (Pubitemid 39600050)
14. U.S. Food and Drug Administration. guidance for industry: clinical pharmacogenomics: premarketing evaluation in early phase clinical studies. Available from http://www.fda.gov/downloads/drugs/guidance complianceregulatoryinformation/ guidances/ucm243702.pdf. Accessed April 1, 2011.
15. Zineh I, Lesko LJ. Pharmacogenetics in medicine: barriers, critical factors and a framework for dialogue. Personalized Medicine 2009;6:359-61.
16. U.S. Food and Drug Administration. guidance: drug safety information, FDA's communication to the public. Available from http://www.fda.gov/downloads/ Drugs/guidanceComplianceRegulatoryInformation/guidances/ucm072281.pdf. Accessed April 1, 2011.
17. Sapsford KE, Tezak Z, Kondratovich M, Pacanowski MA, Zineh I, Mansfield E. Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine. Ther Deliv 2010;1:631-41.