Off-Label Use of Prescription Drugs should be Regulated by the FDA

DSpace/Manakin Repository

Off-Label Use of Prescription Drugs should be Regulated by the FDA

Citable link to this page

. . . . . .

Title: Off-Label Use of Prescription Drugs should be Regulated by the FDA
Author: Tiwary, A Devesh
Citation: Off-Label Use of Prescription Drugs should be Regulated by the FDA (2003 Third Year Paper)
Full Text & Related Files:
Abstract: The FDA does not subject all uses of drugs to a rigorous approval process. There are many justifications given for this. I lay out a system that divides drug-indication sets into four categories: (1) FDA approved; (2) effective; (3) insufficient information; and (4) ineffective. Each category is treated differently so manufacturers have an incentive to get as many indications into the FDA approved category as possible. Physicians will be required to submit de-identified patient data and when prescribing drugs for indications that have insufficient data. They, or their patients, may not be reimbursed for that care unless it is part of a study. My system saves money, improves health care, and advances medical knowledge at the cost of decreased physician autonomy and possibly slightly higher regulatory cost to drug manufacturers.
Terms of Use: This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAA
Citable link to this page: http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852151

Show full Dublin Core record

This item appears in the following Collection(s)

 
 

Search DASH


Advanced Search
 
 

Submitters