The regulation of home diagnostic tests for genetic disorders: can the FDA deny a premarket application on the basis of the device's social impacts?
This article discusses the Food and Drug Administration (FDA) authority to regulate home use diagnostics for genetic disorders based on the social effects of the devices in the premarket approval process (PMA). It begins with a discussion of the potential social impacts of home use genetic diagnostics, focusing particularly on the psychological effects of the devices. The article then discusses the FDA's past experience in regulating home use diagnostics for HIV and for drugs of abuse testing under its PMA authority. In approving PMA applications for home tests for HIV and drugs of abuse, the FDA has considered various social effects of the devices and tailored its approval to these considerations. However, the agency did not deny approval because of social considerations. The author argues that the FDA's past experience in approving PMA applications indicates both a willingness to consider social considerations in the PMA process and that the agency may deny a PMA application based on social considerations in appropriate circumstances. The author also argues that the FDA may deny application if the social impacts and other health risks of the device greatly outweigh the therapeutic benefits of the device. For example, in applications involving late onset genetic disorders for which no therapeutic options currently exist, the social risks of the device may be found to outweigh the benefits to health and therefore the FDA may deny a PMA application in these situations.
Gallagher, Callahan & Gartreee, Concord, NH, USA.
James D
JD
Kerouac
D018795:Device Approval / Q000331:legislation & jurisprudence*; D030342:Genetic Diseases, Inborn / Q000175:diagnosis / Q000523:psychology; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000379:methods* / Q000523:psychology; D033161:Government Regulation; D015658:HIV Infections / Q000175:diagnosis; D006801:Humans; D011933:Reagent Kits, Diagnostic; D012648:Self Care / Q000523:psychology; D012922:Social Change; D015813:Substance Abuse Detection / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration
D011933:Reagent Kits, Diagnostic