RT Journal
A1 Rogers DA, Bellin EH, Harris L, Moore L
T1 THe package insert
JF JAMA
JO JAMA
YR 1969
FD August 25
VO 209
IS 8
SP 1224
OP 1224
DO 10.1001/jama.1969.03160210056022
UL http://dx.doi.org/10.1001/jama.1969.03160210056022
AB To the Editor:— 
    The article, "Notes on the Package Insert" (207:1335, 1969), together with the companion editorial raises two questions.First, although it was noted in the article that the package insert must meet requirements of the "full disclosure" regulation, ie, must contain all available information concerning "drug usage" efficacy, contraindications, and indications," why did not the editorial suggest, let alone stress, that it is the responsibility of the physician to read the package insert.Second, the editorial concluded that "the Council on Drugs emphasize that the package insert is... not a legal restriction on the careful and thoughtful use of a drug by an informed physician." We would like to know how the physician can be "informed" and how he can use the drug carefully and thoughtfully if he has not mastered the only authorized prescribing facts conveniently available to him.In order to further the concept of