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Food and drug administration’s regulatory shift on direct‐to‐consumer genetic tests for cancer risk
Author(s) -
Yang Y. Tony,
Zettler Patricia J.
Publication year - 2019
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.31773
Subject(s) - food and drug administration , medicine , confidentiality , genetic testing , regulatory science , administration (probate law) , direct to consumer advertising , autonomy , drug , drug administration , consumer safety , internet privacy , public economics , marketing , environmental health , business , risk analysis (engineering) , pharmacology , political science , medical prescription , law , economics , pathology , computer science
Although the US Food and Drug Administration’s recent regulatory shift on direct‐to‐consumer genetic tests for cancer risk may increase access to beneficial, innovative devices, it will be critical for regulators, consumers, and the medical community to think through important remaining regulatory, social, and ethical questions to ensure that consumers’ autonomy, privacy, confidentiality, and health are appropriately protected.