Approval of new drugs by the U. S. food and drug administration: Problems with the process and access to unapproved drugs

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Hoeft-Loyer, Christine M
Terminally ill legal status; laws; etc. United States; Drugs Safety regulations United States; United States; Food and Drug Administration; Health and Medical Administration
thesis / dissertation description
Today, the vast majority of drugs available for patient use have gone through a rigorous system of human clinical trials supervised by the Food and Drug Administration (FDA), to ensure the drugs are safe and efficacious. There are now citizen advocacy groups that seek use of drugs not yet approved by the FDA, to be administered to terminally ill patients who have exhausted all other available means of therapy. The FDA has programs for terminal patients, under the supervision of their physicians, to use unapproved drugs; however, the advocacy groups seek access to drugs in much earlier phases than is now allowed, raising serious safety concerns for patients. Use of drugs outside of the clinical trials system undermines the integrity of the FDA’s drug development process by slowing enrollment, which in turn slows approval and timely access of safe and efficacious drugs to all of society.