Document Title
Over-the-Counter Drugs: Proposed Labeling Requirements. Letter to Food and Drug Adminstration.
Keywords
Drug Industry;Patient Advocacy;United States Food and Drug Administration
Creation Date
Modified Date
Pages
2
Document Adobe Metadata
{"Producer":"Acrobat 4.0 Scan Plug-in for Windows\u0000","Creator":"Acrobat 4.0 Capture Plug-in for Windows\u0000","Keywords":"Drug Industry;Patient Advocacy;United States Food and Drug Administration","ModDate":"2001-04-19T14:45:07-04:00","Abstract":"Each of the undersigned physician organizations IS in the process of reviewing the Food and Drug Administration's (FDA) Proposed rule, \"Over-The-Counter Human Drugs: Proposed Labeling Requirements\". However, our organizations are deeply concerned by the FDA's suggestion that the phrase \"Ask your doctor\" be changed to \"Ask your doctor or pharmacist\" on over-the-counter (OTC) drug product labeling for certain products. Therefore, we wish to express our collective and emphatic opposition to this specific proposal at this time. Such a change in OTC drug product labeling would inappropriately elevate the pharmacist to the same level as the physician regarding both the evaluation of patient-specific conditions, symptoms, side effects, concomitant therapies, and \"off-label\" dosages associated with the use of OTC drug products and the provision of diagnostic and treatment recommendations to individual patients.","Title":"Over-the-Counter Drugs: Proposed Labeling Requirements. Letter to Food and Drug Adminstration.","DocType":"Regulatory Response","CreationDate":"2001-04-19T14:43:32-04:00","DateApproved":"1997-10-03","Pages":2}
Document Type Year
1997