Genetic testing and FDA regulation: Overregulation threatens the emergence of genomic medicine

JAMA - Journal of the American Medical Association

Volumn 313, Issue 7, 2015, Pages 669-670

  Evans, James P ^a   Watson, Michael S ^b,c  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b American College of Medical Genetics   (United States)

^c ACMG Foundation for Genetic and Genomic Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; FOOD AND DRUG ADMINISTRATION; GENETIC DISORDER; GENETIC SCREENING; GENOME ANALYSIS; GOVERNMENT REGULATION; HEALTH CARE COST; HEALTH CARE POLICY; HUMAN; MEDICAL DEVICE; MEDICAL RESEARCH; MEDICAL SERVICE; MEDICAL SOCIETY; NOTE; ORGANIZATIONAL DOWNSIZING; OUTCOME ASSESSMENT; PATIENT ASSESSMENT; PRIORITY JOURNAL; PROCESS DEVELOPMENT; SEQUENCE ANALYSIS; STRATEGIC PLANNING; GENOMICS; LEGISLATION AND JURISPRUDENCE; PERSONALIZED MEDICINE; STANDARDS; UNITED STATES;

GENETIC TESTING; GENOMICS; GOVERNMENT REGULATION; HUMANS; INDIVIDUALIZED MEDICINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84923165887     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.2014.18145     Document Type: Note

References (9)

1. US Food and Drug Administration (FDA). FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs) [draft guidance]. FDA website. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM416684.pdf. Accessed December 22, 2014.
2. Yang Y, Muzny DM, Xia F, et al. Molecular findings among patients referred for clinical whole-exome sequencing. JAMA. 2014;312(18): 1870-1879.
3. Lee H, Deignan JL, Dorrani N, et al. Clinical exome sequencing for genetic identification of rare mendelian disorders. JAMA. 2014;312(18):1880-1887.
4. 21st-Century Cures: Examining the Regulation of Laboratory Developed Tests: Hearings Before the Subcommittee on Health, Committee on Energy and Commerce, US House of Representatives, 113th Cong, 4th Sess (2014) (testimony of Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health, US Food and Drug Administration).
5. American Medical Association (AMA). AMA Statement on FDA Proposal Regarding Diagnostic Testing. AMA website. http://www.ama-assn.org/ama/pub/news/news/2014/2014-08-01-fda-proposal-diagnostic-testing.page. August 1, 2014. Accessed December 22, 2014.
6. Gostin LO. Who owns human genes? is DNA patentable? JAMA. 2013;310(8):791-792.
7. Office of Science Policy, National Institutes of Health (NIH). Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests. NIH website. http://osp.od.nih.gov/sites/default/files/SACGHS-patents-report-2010.pdf. Accessed December 22, 2014.
8. Javitt G. FDA's Legally-Suspect Shift of Clinical Lab Test Regulation Through Guidance Documents. Washington Legal Foundation Legal Pulse website. http://wlflegalpulse.com/2014/08/20/fdas-legally-suspect-shift-of-clinical-lab-test-regulation-through-guidance-documents/. Accessed December 22, 2014.
9. Overley J. Lab Group Taps Paul Clement, Laurence Tribe for FDA Battle. Law 360 website. http://www.law360.com/articles/597197/lab-group-taps-paul-clement-laurence-tribe-for-fda-battle. Accessed December 22, 2014.