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Pediatric Drug Labeling and Imperfect Information
Author(s) -
Wilfond Benjamin S.
Publication year - 2020
Publication title -
hastings center report
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.515
H-Index - 63
eISSN - 1552-146X
pISSN - 0093-0334
DOI - 10.1002/hast.1074
Subject(s) - pulmonologist , advisory committee , bioethics , food and drug administration , ethical issues , curiosity , psychology , medicine , family medicine , law , political science , engineering ethics , social psychology , medical emergency , public administration , intensive care medicine , engineering
I first became aware of bioethics in the spring of 1980. I had spent a thirty‐six‐hour shift shadowing a medical resident, and I was struck that many of the resident's decisions had ethical dimensions. The next day, I came across the Hastings Center Report, and I realized I wanted to explore ethical issues I found implicit in clinical care, even though I still wanted to become a pediatrician. In September 2019, when I attended my first meeting of the U.S. Food and Drug Administration's Pediatric Advisory Committee, as a pediatric pulmonologist, I had the same sense of awe and curiosity that I had forty years ago. What had appeared initially as somewhat technical decisions about the regulation of drug labeling was suffused with ethical questions. The committee was asked to discuss possible changes to the labeling of two previously approved drugs .